FDALiveFDALive.com

The World's Leading Source for FDA Broadcasting

Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Adcomm - Teva Pharma

Meeting Date: 12/9/15-12/10/15

Meeting Details:

On Day 1 - December 9, 2015 - The committee will discuss biologics license application 761033, reslizumab for injection, submitted by Teva Pharmaceutical Industries, Ltd., for the proposed indication to reduce exacerbations, relieve symptoms, and improve lung function in adults and adolescents 12 years of age and above, with asthma and elevated blood eosinophils, who are inadequately controlled on inhaled corticosteroids. On Day 2 - December 10, 2015 - The committees will discuss the safety of codeine in children 18 years of age and younger. Codeine (most often in combination with acetaminophen) is used for the treatment of pain in children; however, it is contraindicated for the management of pain after tonsillectomy and/or adenoidectomy. Codeine (in combination with other medicines) is used for the relief of cough associated with upper respiratory allergies or the common cold in children. Codeine is available by prescription and also through the over-the-counter (OTC) Drug Monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products (21 CFR 341.14, 21 CFR 341.74, and 21 CFR 341.90). The focus of the meeting will be the risk of serious adverse events, such as respiratory depression and death, including reports in children who are CYP2D6 ultra-rapid metabolizers. The committees will discuss whether the use of codeine in children should be restricted further beyond the current contraindication described previously and whether codeine should be available through the OTC Drug Monograph.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPCNS AdComm - drisapersen by BioMarin Pharma

Meeting Date: 11/24/15-11/24/15

Meeting Details:

The committee will discuss new drug application (NDA) 206031, drisapersen solution for injection, sponsored by BioMarin Pharmaceutical Inc., for the treatment of patients with Duchenne muscular dystrophy with mutations in the dystrophin gene that are amenable to treatment with exon 51 skipping as determined by genetic testing.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Adcomm

Meeting Date: 6/11/15-6/11/15

Meeting Details:

The committee will discuss biologics license application (BLA) 125526, for mepolizumab for injection, submitted by GlaxoSmithKline for the proposed indication of add-on maintenance treatment in patients 12 years and older with severe eosinophilic asthma identified by blood eosinophils greater than or equal to 150 cells/microliter at initiation of treatment or blood eosinophils greater than or equal to 300 cells/microliter in the past 12 months

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Adcomm

Meeting Date: 5/12/15-5/12/15

Meeting Details:

The committee will discuss new drug application (NDA) 206038, lumacaftor/ivacaftor combination tablets for oral use, submitted by Vertex Pharmaceuticals, proposed for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 3/19/15-3/19/15

Meeting Details:

The committees will discuss supplemental new drug application 204275-S001, for fluticasone furoate and vilanterol inhalation powder (tradename Breo Ellipta) submitted by GlaxoSmithKline for the once daily maintenance treatment of asthma in patients 12 years of age and older. The discussion will include efficacy data, but the focus of the meeting will be safety, including the adequacy of the safety database to support approval, and whether a large safety trial to evaluate serious asthma outcomes is recommended.

 

       
Location: Holiday Inn Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 10/21/14-10/21/14

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 203188, ivacaftor oral tablets, submitted by Vertex Pharmaceuticals Inc., for the treatment of cystic fibrosis in patients with an R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 8/14/14-8/14/14

Meeting Details:

he committee will discuss the new drug application (NDA) 21936, for tiotropium bromide inhalation spray, submitted by Boehringer Ingelheim Pharmaceuticals, Inc. for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations. The discussion will include efficacy data, including the data to support the claim for reduction of COPD exacerbations, but the focus will be on safety findings from the clinical development program and the results of a large safety trial comparing tiotropium bromide inhalation spray and tiotropium bromide inhalation powder.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 9/10/13-9/10/13

Meeting Details:

On September 10, 2013, the committee will discuss the new molecular entity new drug application (NDA) 203975, for umeclidinium and vilanterol powder for inhalation (proposed trade name Anoro Ellipta), sponsored by Glaxo Group (d/b/a/GSK) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 4/17/13-4/17/13

Meeting Details:

The committee will discuss the new drug application (NDA) 204275, for fluticasone furoate and vilanterol dry powder inhaler (proposed trade name BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 3/7/13-3/7/13

Meeting Details:

On March 7, 2013, the committee will discuss the new drug application (NDA) 204275, for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 1/30/13-1/30/13

Meeting Details:

The committee will discuss the new drug application (NDA) 202049, for mannitol inhalation powder (proposed trade name BRONCHITOL), for oral inhalation sponsored by Pharmaxis, for the proposed indication of management of cystic fibrosis (CF) in patients aged 6 years and older to improve pulmonary function.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 1/29/13-1/29/13

Meeting Details:

The committee will discuss the new drug application (NDA) 203108, for olodaterol (proposed trade name Striverdi Respimat) metered dose inhaler, sponsored by Boehringer Ingelheim, for the proposed indication of long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 1/29/13-1/29/13

Meeting Details:

The committee will discuss the new drug application (NDA) 203108, for olodaterol (proposed trade name Striverdi Respimat) metered dose inhaler, sponsored by Boehringer Ingelheim, for the proposed indication of long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 2/23/12-2/23/12

Meeting Details:

The committee will discuss new drug application 202450, for aclidinium bromide, sponsored by Forest Laboratories, for the proposed indication of long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsFirazyr by Shire - Pulmonary-Allergy Drugs AdComm

Meeting Date: 6/23/11-6/23/11

Meeting Details:

On June 23, 2011, the committee will discuss the new drug application (NDA) 22150, icatibant solution for injection (proposed tradename Firazyr), Shire Human Genetic Therapies, for the proposed indication of treatment of acute attacks of hereditary angioedema

 

       
Location: Silver Spring, Maryland Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy AdComm

Meeting Date: 3/8/11-3/8/11

Meeting Details:

The Committee will discuss new drug application (NDA) No. 22-383, indacaterol maleate (Arcapta™ Neohaler™) by Novartis Pharmaceuticals Corporation, for the long-term once daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 4/7/10-4/7/10

Meeting Details:

On April 7, 2010, the committee will discuss new drug application (NDA) 22–522, roflumilast (DAXAS), Forest Research Institute, for the maintenance treatment of chronic obstructive pulmonary disease associated with chronic bronchitis in patients at risk of exacerbations (worsening symptoms).

 

       
Location: Hilton Silver Spring MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 3/10/10-3/11/10

Meeting Details:

On March 10 and 11, 2010, the committee will discuss the design of medical research studies (known as ``clinical trial design'') to evaluate serious asthma outcomes (such as hospitalizations, a procedure using a breathing tube known as intubation, or death) with the use of the class of asthma medications known as long acting beta-2 adrenergic agonists in the treatment of asthma in adults, adolescents, and children.

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 3/9/10-3/9/10

Meeting Details:

The committee will discuss new drug application (NDA) 22-535, pirfenidone, by InterMune. The proposed indication (purpose) of this drug is the treatment of patients with idiopathic pulmonary fibrosis (scarring of the lungs without a known cause) to decrease the decline in lung function associated with this condition.

 

       
Location: Hilton Washington Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 11/18/09-11/20/09

Meeting Details:

DAY 1: The committee will discuss biologics license application (BLA) 103976, supplement 5149, for XOLAIR (omalizumab), manufactured by Genentech USA, Inc. and Novartis Pharmaceuticals Corp. The proposed indication for this product is to treat moderate to severe persistent asthma in patients between 6 and 11 years of age whose symptoms are inadequately controlled with inhaled steroid medications and have: (1) A positive reaction to skin testing with common substances that can cause allergies and asthma, such as pollen or (2) in vitro reactivity, which is measured with a blood test that confirms the presence of specific proteins consistent with allergies and asthma. Day 2: The committee will discuss the efficacy supplement for new drug application (sNDA) 21395, for the approved product Spiriva HandiHaler (tiotropium inhalation powder), manufactured by Boehringer Ingelheim, for the reduction in exacerbations (worsening of symptoms) in patients with chronic obstructive pulmonary disease (COPD). Day 3: The committee will discuss new drug application (NDA) 22368, for ARIDOL (mannitol bronchial challenge test), manufactured by Pharmaxis Ltd. The proposed use of this product is to assess bronchial hyperresponsiveness (airway irritability in the lungs) to aid in diagnosing patients 6 years of age or older who have symptoms of asthma or symptoms that are suggestive of asthma.

 

       
Location: Hilton Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 2/4/09-2/4/09

Meeting Details:

The committee will discuss biologics license application (BLA) No. 125277, KALBITOR, for ecallantide injection by Dyax Corp., for the proposed indication of treatment of acute attacks of hereditary angioedema.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy, DSRM, Pediatric AC

Meeting Date: 12/10/08-12/11/08

Meeting Details:

The committees will discuss the benefit risk assessment of long acting beta-2 adrenergic agonists for the treatment of asthma in adults and children.

 

       
Location: Hilton Washington DC/Rockville Rockville Pike, Rockville, MD. Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 2/20/08-2/20/08

Meeting Details:

The committee will discuss the new drug application (NDA) 22- 150, icatibant solution for injection (proposed tradename FIRAZYR), by Jerini, for the proposed indication of treatment of attacks of hereditary angioedema.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 5/1/07-5/1/07

Meeting Details:

The committee will discuss the efficacy supplement to new drug application (NDA) 21-077 for the approved product Advair Diskus(fluticasone propionate/salmeterol inhalation powder) by G1axoSmithKline, for the proposed indication of increased survival and reduced exacerbations in patients with chronic obstructive pulmonary disease (COPD).

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 7/13/05-7/14/05

Meeting Details:

On July 13, 2005, the committee will discuss the implications of recently available data related to the safety of long-acting beta-agonist bronchodilators. On July 14, 2005, the committee will discuss the continued need for the essential use designations of prescription drugs for the treatment of asthma and chronic obstructive pulmonary disease under 21 CFR 2.125.

 

       
Location: Hilton Washington DC North Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 6/6/05-6/6/05

Meeting Details:

The committee will consider the safety and efficacy of new drug application (NDA) 50-799, proposed trade name PULMINIQ (cyclosporine, inhalation solution) Chiron Corporation, for use in combination with standard immunosuppressive therapy to increase survival and prevent chronic rejection in patients receiving allogenic lung transplants.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 6/10/04-6/10/04

Meeting Details:

The committee will discuss the possible removal of the essential use designation of albuterol under 21 CFR 2.125.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 9/5/03-9/5/03

Meeting Details:

On September 5, 2003, the FDA will discuss NDA 21-573 Ariflo by GSK for the use in chronic obstructive pulomnary disease.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 5/15/03-5/15/03

Meeting Details:

The committee will discuss biologics license application (BLA) 103976, Xolair Omalizumab (Humanized Monoclonal Antibody to Human IgE) by Genentech Incorporated, for the treatment of allergic asthma.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 12/20/02-12/20/02

Meeting Details:

MEETING POSTPONED UNTIL 2003: The committee will discuss new drug application (NDA) 20- 959, Ebastine by Almirall Prodesfarma, for the proposed indication of relief of nasal and nonnasal symptoms associated with seasonal and perennial allergic rhinitis in adults and children 12 years of age and older.

 

       
Location: Holiday Inn in Gaithersburg, Md. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 9/6/02-9/6/02

Meeting Details:

The committee will discuss new drug application (NDA) 21- 395, SPIRIVA (Tiotropium bromide) by Boehringer-Ingelheim, for chronic obstructive pulmonary disease.

 

       
Location: Holiday Inn Gaithersburg Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary & Allergy Drugs Advisory Committee

Meeting Date: 1/17/02-1/17/02

Meeting Details:

The committee will discuss the use of Flovent Diskus (NDA# 20-833) and Advair Diskus (NDA# 21-077) as maintenance therapy in patients with Chronic Obstructive Pulmonary Disease (COPD).

 

       
Location: Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 11/22/99-11/23/99

Meeting Details:

On November 22, 1999, the FDA will discuss its regulations related to ozone-depleting substances. In this discussion, FDA will review the Montreal Protocol on substances that deplete the ozone layer and the Advanced Notice of Proposed Rulemaking (ANPR) published on March 6, 1997 (FR Vol.62, No. 4410242), as discussed at the April 11, 1997, PADAC. The FDA will provide an overview and detailed discussion of the notice of proposed rulemaking (NPR),published on September 1, 1999 (FR Vol. 64 No. 169 47719), related to the phase-out of chloroflurocarbons (CFCs) in metered-dose inhalers. This NPR outlines the mechanism by which FDA will determine when the use of ozone-depleting substances, including CFCs in metered-dose, inhalers, in any product regulated by FDA is no longer essential under the Clear Air Act. On November 23, 1999, the committee will discuss the safety and 0efficacy of new drug application (NDA) 21-077 for three products: Advair™ Diskus® 100 mcg (salmeterol xinafoate 50 mcg/fluticasone propionate 100 mcg inhalation powder), Advair™ Diskus® 250 mcg (salmeterol xinafoate 50 mcg/fluticasone propionate 250 mcg inhalation powder), Advair™ Diskus® 500 mcg (salmeterol xinafoate 50 mcg/fluticasone propionate 500 mcg inhalation powder), Glaxo Wellcome, for the maintenance treatment of asthma as prophylatic therapy in patients 12 years of age and older.

 

       
Location: Holiday Inn Bethesda, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs

Meeting Date: 12/15/97-12/15/97

Meeting Details:

The Committee will discuss the safety and efficacy of new drug application (NDA) 20-793, Cafcit (caffeine citrate injection, 10 milligram/milliliter), Roxane Laboratories, Inc., for intravenous or oral use in the treatment of apnea of prematurity.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary Allergy Drugs Advisory Committee

Meeting Date: 4/11/97-4/11/97

Meeting Details:

FDA staff will present to the committee the agency's advance notice of proposed rulemaking, which proposes a strategy for the withdrawal of the essential use status of marketed chlorofluorocarbon (CFC) products as proven alternatives become available. A representative from the U.S. Environmental Protection Agency will present an overview of the environmental impact of CFC's and a review of the Montreal Protocol on ozone-depleting substances. The committee will discuss and comment upon the agency's proposed strategy for the CFC-transition process and on presentations made during the open public hearing. Advisory committee input, in addition to open public hearing comments, will be considered by the agency as it formulates subsequent rulemaking related to the CFC-transition process.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Nonprescription and the Pulmonary-Allergy Drugs Advisory Committee

Meeting Date: 10/10/96-10/10/96

Meeting Details:

On October 10, 1996, the committees will jointly consider NDA 20-463, Nasalcrom (Cromolyn Sodium Nasal Solution, United States Pharmacopeia) for OTC treatment of seasonal allergic rhinitis sponsored by McNeil Consumer Products Co. On October 11, 1996, the committees will jointly consider the prescription to OTC switch of NDA 19-589, Vancenase AQ Nasal Spray (Beclomethasone Dipropionate) for the treatment of seasonal allergic rhinitis sponsored by Schering-Plough Pharmaceutical Co. National Mammography Quality Assurance Advisory Committee

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 10/9/96-10/9/96

Meeting Details:

The committee will discuss Genentech's clinical labeling supplement to modify the current prescribing information for Pulmozyme (dornase alfa) pertaining to cystic fibrosis patients with forced vital capacity of the lung, less than 40 percent of predicted capacity.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 3/28/96-3/29/96

Meeting Details:

On March 28, 1996, the committee will discuss Zeneca Pharmaceuticals' new drug application (NDA) 20-547 for Accolate (zafirlukast) tablets. The proposed indication for Accolate is as an oral anti-inflammatory agent for use in the prophylaxis and chronic treatment of asthma and as a first-line maintenance therapy in patients with asthma who are not adequately controlled by PRN 2-agonist alone. On March 29, 1996, the committee will discuss 3M Pharmaceuticals' NDA 20-503 for Epaq TM, an albuterol metered-dose inhaler which is the first to utilize a hydrofluoroalkane propellent. The proposed indication is for treatment or prevention of bronchospasm in patients with reversible obstructive airway disease.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 11/17/95-11/17/95

Meeting Details:

The committee will be briefed on the Pediatric Labeling Rule and the data necessary to support pediatric labeling of drugs. The committee will discuss NDA 20-114, Astelin nasal spray (azelastine), for seasonal allergic rhinitis. The sponsor is Carter-Wallace, Inc.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 11/16/95-11/16/95

Meeting Details:

The committees will first discuss data relevant to investigational new drug (IND) 41,743, sponsored by Sandoz Pharmaceuticals Corp., on the efficacy of clemastine fumarate in the common cold. The committees will then discuss a meta-analysis of data on antihistamines and the common cold to address the inclusion of the common cold indication for the over-the-counter antihistamines, which is currently in the tentative final monograph, in the final monograph.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs

Meeting Date: 9/25/95-9/25/95

Meeting Details:

The committee will discuss two NDA's: (1) NDA 20-548, Flovent TM Inhalation Aerosol (a metered-dose inhaler formulation of fluticasone propionate), and (2) NDA 20-549, Flovent TM Inhalation via Diskhaler (a dry powder formulation of fluticasone propionate). Both NDA's are indicated for the maintenance treatment of bronchial asthma and for treatment of patients requiring oral corticosteroid therapy for asthma who may be able to significantly reduce or eliminate their requirement for oral corticosteroids over time. The sponsor for both NDA's is Glaxo Welcome.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs

Meeting Date: 4/10/95-4/10/95

Meeting Details:

The committee will discuss new drug application (NDA) 20-471, Abbott Laboratories, Leutrol (zileuton) as an anti-asthmatic drug.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Pulmonary-Allergy Drugs

Meeting Date: 11/14/94-11/15/94

Meeting Details:

The committees will jointly discuss over-the-counter (OTC) drug products for the treatment of asthma and will address topics such as: (1) OTC bronchodilator drug products currently available and possible pending changes in their marketing status; (2) whether there is a population for which OTC antiasthma drug products are appropriate; (3) the general question of whether antiasthma drug products should be available OTC; (4) antiasthma drug products currently available by prescription only that could be considered for OTC status; and (5) data requirements necessary to support conversion of prescription antiasthma drug products to OTC status.

 

       
Location: November 14, 1994, 8:30 a.m., Parklawn Bldg., conference rms. G through J, FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs

Meeting Date: 7/14/94-7/15/94

Meeting Details:

On July 14, 1994, the committee will discuss new drug application (NDA) 20-291, Boehringer Ingelheim Pharmaceuticals, Inc., Combivent Inhalation Aerosol: (ipratropium bromide and albuterol sulfate) for the treatment of bronchospasm associated with chronic obstructive pulmonary disease. The committee will also be briefed on general points to consider for inhalational drug product development. On July 15, 1994, the committee will discuss: (1) NDA 20-393, Boehringer Ingelheim Pharmaceuticals, Inc., Atrovent Nasal Spray 0.03% (ipratropium bromide) for the symptomatic relief of rhinorrhea associated with perennial rhinitis, and (2) NDA 20-394, Boehringer Ingelheim Pharmaceuticals, Inc., Atrovent Nasal Spray 0.06% (ipratropium bromide) for the symptomatic relief of rhinorrhea associated with the common cold. Closed committee deliberations. The committee will discuss trade secret and/or confidential commercial information relevant to pending NDA's. This portion of the meeting will be closed to permit discussion of this information (5 U.S.C. 552b(c)(4)).

 

       
Location: July 14 and 15, 1994, 8 a.m., Parklawn Bldg., conference rms. D and E, FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding AdComm

Meeting Date: 5/8/17-5/9/17

.

Meeting Details:

The committee will receive updates on certain issues to follow up on discussions from previous meetings, including quality standards and conditions at certain compounding facilities. In addition, the committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A Bulks List. FDA will discuss the following nominated bulk drug substances: nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl sulfate, and artemisinin. The chart below describes which use(s) FDA reviewed for each of the six bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs AdComm

Meeting Date: 5/10/17-5/10/17

.

Meeting Details:

The committee will discuss new drug application (NDA) 208-630 for 5-Aminolevulinic Acid Hydrochloride [5-ALA HCl], Powder, for oral solution, submitted by NX Development Corp., for the proposed indication as an imaging agent to facilitate the real time detection and visualization of malignant tissue during glioma surgery.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel of the Medical Devices AdComm

Meeting Date: 5/17/17-5/17/17

.

Meeting Details:

On May 17, 2017, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the TRANSMEDICS ORGAN CARE SYSTEM (OCS)--Lung System, by TransMedics, Inc. The proposed Indication for Use, as stated in the PMA, is as follows: The TRANSMEDICS ORGAN CARE SYSTEM (OCS) Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state for transplantation.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 5/17/17-5/17/17

.

Meeting Details:

On May 17, 2017, the VRBPAC will meet in an open session to discuss considerations for evaluation of Respiratory Syncytial Virus vaccine candidates in seronegative infants.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-4:45PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Pediatric AdComm and the Pediatric Ethics Subcommittee

Meeting Date: 5/18/17-5/18/17

.

Meeting Details:

On May 18, 2017, the PAC and the PES will meet to discuss a referral by an Institutional Review Board (IRB) of a clinical investigation that involves children and FDA regulated products. The clinical investigation is entitled “A Double-Blind, Placebo-Controlled, Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP 4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy.” Comments about the upcoming joint meeting should be submitted to Docket No. FDA 2017-N-1780.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-5:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 5/24/17-5/25/17

.

Meeting Details:

On May 24th during the morning session, the committee will discuss new drug application (NDA) 208051, for neratinib maleate, an application submitted by Puma Biotechnology. The proposed indication (use) for this product is as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant traustuzumab-based therapy. During the afternoon session, the committee will discuss NDA 208587, for L-glutamine powder (oral solution), submitted by Emmaus Medical, Inc. The proposed indication (use) for this product is for the treatment of sickle cell disease. On May 25th the committee will discuss biologics license application (BLA) 125545, for a proposed biosimilar to Amgen Inc.'s Epogen/Procrit (epoetin alfa), submitted by Hospira Inc., a Pfizer company. The proposed indications/uses for this product are: (1) For the treatment of anemia due to chronic kidney disease, including patients on dialysis and not on dialysis, to decrease the need for red blood cell (RBC) transfusion; (2) for the treatment of anemia due to zidovudine administered at = 4,200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of = 500 m units/mL; (3) for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppresive chemotherapy, and upon initiation, there is a minimum of 2 additional months of planned chemotherapy; and (4) to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to <13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, and nonvascular surgery.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 4/13/17-4/13/17

Meeting Details:

The committee will discuss the development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections; examples of such drugs include those that are only active against Pseudomonas aeruginosa or Acinetobacter baumannii.

 

       
Location: Tommy Douglas Conference Center Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Anesthetic and Analgesic Drug Products AdComm and DSRM AdComm

Meeting Date: 4/5/17-4/5/17

Meeting Details:

The committees will discuss new drug application (NDA) 209777, for oxycodone hydrochloride immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC., with the proposed indication of management of moderate to severe pain where the use of an opioid analgesic is appropriate. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 9:15AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting Nonprescription AdComm & DSRM AdComm

Meeting Date: 4/4/17-4/4/17

Meeting Details:

The committees will discuss safety issues associated with over-the-counter analgesic combination products used for upset stomach (i.e., heartburn, nausea, fullness, belching, gas, acid indigestion, and/or sour stomach) and hangover indications under the Internal Analgesic and Antacid monographs in 21 CFR part 343 and 21 CFR part 331, respectively. The committees will also be asked to discuss the hangover indication under the Overindulgence, Internal Analgesic, and Stimulant monographs in 21 CFR part 357 subpart J, 21 CFR part 343, and 21 CFR part 340, respectively.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 4/4/17-4/5/17

Meeting Details:

On April 4, 2017, in open session, the Committee will discuss Recombinant Human Coagulation Factor IX, GlycoPEGylated. In the afternoon, in open session, the Committee will hear an update presentation on a summary of responses to Docket FDA-2016-N-1502: Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. On April 5, 2017, in open session, the committee will hear overview presentations on the research programs in the Laboratory of Emerging Pathogens in the Division of Emerging Transfusion-Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. At the conclusion of the open session, the meeting will be closed to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6). During the closed session, the Committee will discuss the research progress made by staff involved in the intramural research programs and make recommendations regarding their personnel actions and staffing decisions.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:30AM-3:45PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 3/29/17-3/29/17

Meeting Details:

During the morning session of March 29, 2017, the committee will discuss biologics license application (BLA) 761064, rituximab/hyaluronidase injection for subcutaneous use, submitted by Genentech, Inc. The proposed indications (uses) for this product are for: (1) The treatment of patients with relapsed or refractory, follicular lymphoma as a single agent; (2) previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab/hyaluronidase for subcutaneous injection in combination with chemotherapy, as single-agent maintenance therapy; (3) nonprogressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; (4) the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) or other anthracycline based chemotherapy regimens; and (5) in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated chronic lymphocytic leukemia (CLL). During the afternoon session, the committee will discuss new drug application (NDA) 209099, for binimetinib, submitted by Array BioPharma Inc. The proposed indication (use) for this product is for the treatment of patients with unresectable or metastatic melanoma, with NRAS Q61 mutation as detected by an FDA-approved test, who have received prior treatment with checkpoint inhibitor therapy.

 

       
Location: Sheraton Related News Links: Not Available
Time: 8:00AM-12:30PM    
Materials:
   
       

View Meeting Details / News

Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

Live Meetings

There are no Live Broadcasts available at this time.