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 OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 4/19/18-4/19/18

.

Meeting Details:

The committee will discuss new drug application (NDA) 210365, cannabidiol oral solution, sponsored by GW Pharmaceuticals, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-1:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 4/23/18-4/23/18

.

Meeting Details:

The committee will discuss the new drug application (NDA) 207924, for baricitinib tablets, submitted by Eli Lilly and Company, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The discussion will include the following: efficacy, safety, including the risk of thromboembolic adverse events, dose selection, and overall risk benefit considerations.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis and DSRM AdComm

Meeting Date: 4/24/18-4/25/18

.

Meeting Details:

The committees will be asked to discuss supplemental new drug application (sNDA) 20998 for CELEBREX (celecoxib) capsules submitted by Pfizer, Inc., which includes the results from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial, a cardiovascular outcomes randomized controlled trial that compared celecoxib to ibuprofen and naproxen, and determine whether the findings of the trial change FDA’s current understanding of the safety of these three NSAIDs. In order to interpret some of the PRECISION findings, the committees will also consider the clinical implications of the drug interactions between each of these three NSAIDs and aspirin in patients taking aspirin for secondary prevention of cardiovascular disease.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 5/1/18-5/1/18

.

Meeting Details:

The committee will discuss new drug application (NDA) 208627 for tecovirimat, sponsored by SIGA Technologies Inc., for the proposed indication of the treatment of smallpox disease caused by variola virus in adults and pediatric patients. This product was developed under the Animal Rule (21 CFR part 314, subpart I).

 

       
Location: FDA Meeting Room - Out of WO Related News Links: Not Available
Time: 10:00AM-4:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 5/2/18-5/2/18

.

Meeting Details:

The committee will discuss new drug application (NDA) 210303 for plazomicin, sponsored by Achaogen, Inc., for the proposed indications for the treatment of complicated urinary tract infections and blood stream infections in adults.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastro and Pediatric AdComm

Meeting Date: 5/3/18-5/3/18

.

Meeting Details:

The committees will discuss new drug application (NDA) 209904, for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/10/18-5/10/18

.

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 210645, for volanesoren solution for subcutaneous injection, submitted by Akcea Therapeutics, Inc. The proposed indication is as an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic with DSRM AdComm

Meeting Date: 5/22/18-5/22/18

.

Meeting Details:

The committees will be asked to discuss new drug application (NDA) 209588, for buprenorphine sublingual spray, submitted by INSYS Development Company, Inc., for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate. The committees will also be asked to discuss whether this product should be approved.

 

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

View Meeting Details / News

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry & Clinical Toxicology Devices Panel of the Medical Devices AdComm

Meeting Date: 3/29/18-3/30/18

Meeting Details:

On March 29, 2018, the committee will discuss, make recommendations, and vote on information regarding a premarket approval application to market a novel continuous glucose monitoring (CGM) device system, the Senseonics, Inc. Eversense CGM System. This device requires minor surgery to implant and remove, and if approved, would provide 90 days of sensor glucose values from each implanted sensor. The Eversense CGM System measures patients’ glucose concentrations from subcutaneous interstitial fluid similar to approved CGM systems. All CGM devices currently or previously marketed used electrochemistry to measure glucose in interstitial fluids, last for 3 to 11 days and are inserted via a small-gauge needle by the end user. The proposed CGM system uses a fluorescence-based measurement technique, requires minor surgery for subcutaneous implantation, and will have a 90-day sensor wear period. The proposed CGM sensor also includes a drug component (dexamethasone acetate) intended to mitigate negative effects on sensor accuracy and sensor life from the foreign body response at the sensor insertion site. The proposed intended use, as stated by the sponsor, is as follows: The Eversense CGM System continually measures glucose levels in adults (age 18 and older) with diabetes for the operating life of the sensor. The system is intended to: • Aid in the management of diabetes. • Provide real-time glucose readings. • Provide glucose trend information. • Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia). The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns seen over time. On March 30, 2018, the committee will discuss and make recommendations regarding measuring blood glucose using capillary blood with blood glucose meters in all hospital patients, including those receiving intensive medical intervention/therapy and patients with decreased peripheral blood flow, such as with severe hypotension, shock, hyperosmolar-hyperglycemia and severe dehydration (e.g., patients in intensive care settings). Currently, FDA has cleared one glucose meter for use all over the hospital using venous and arterial blood. FDA understands that being able to make capillary blood measurements in all hospitalized patients using FDA cleared and Clinical Laboratory Improvement Amendments (CLIA) waived (i.e., designated as waived per the standards in the CLIA) glucose meters would be more convenient and timely for hospital staff. FDA would like to present new data from capillary blood measurements on glucose meters in patients receiving intensive medical intervention/therapy to the Clinical Chemistry and Clinical Toxicology Devices Panel. FDA would like to receive feedback from the advisory panel on the benefits and risks of measuring capillary blood using blood glucose meters in this intended use population, and the considerations for CLIA waiver for this use.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 3/27/18-3/27/18

Meeting Details:

The committee will discuss new drug application (NDA) 209229, lofexidine hydrochloride, submitted by US WorldMeds, LLC, for mitigation of symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation treatment.

 

       
Location: Tommy Douglas Conference Center 10000 New Hampshire Ave Silver Spring, MD 20903 Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 3/22/18-3/23/18

Meeting Details:

On Thursday, March 22, 2018, the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia (ACH) submitted by BioMarin Pharmaceutical Inc. The following elements of a phase 3 program should be considered for discussion: evidence required to establish dose-response, study design, e.g., placebo control, study duration, intended population, e.g., infants and toddlers and/or older children and adolescents, and endpoints that have a clinically meaningful impact on the patient’s functional or psychological well-being. On Friday, March 23, 2018, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. The Pediatric Advisory Committee will meet to discuss the following products (listed by FDA Center): 1) Center for Drug Evaluation and Research BANZEL, INTUNIV, LEXAPRO 2) Center for Devices and Radiological Health FLOURISH (HDE), ACTIVA (HDE), LIPOSORBER (HDE), IMPELLA RP SYSTEM (HDE)

 

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