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- Joint Meeting Anesthetic & Analgesic with DSRM AdComm
Meeting Date: 2/14/18-2/15/18
The committees will be asked to discuss new drug application (NDA) 209257, proposed tradename, HYDEXOR, a fixed-dose combination oral tablet, submitted by Charleston Laboratories, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short-term management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting. The committees will also be asked to discuss the abuse potential of this non-abuse-deterrent product and whether it should be approved. The committee will discuss supplemental new drug application (sNDA) 022496/S-009, for EXPAREL (bupivacaine liposomal injectable suspension), submitted by Pacira Pharmaceuticals, Inc., to produce local analgesia and as a nerve block to produce regional analgesia.
|Location:||FDA Meeting Room||Related News Links:||Not Available|
- Neurological Devices Panel of the Medical Devices
Meeting Date: 3/1/18-3/1/18
On March 1, 2018, the committee will discuss, make recommendations, and advise FDA regarding the evaluation of clinical study data to support the safety and effectiveness of intracranial aneurysm treatment devices and factors that can affect clinical outcomes such as aneurysm morphology, size, and location in the neurovasculature. FDA is also convening this committee to seek expert opinion on the scientific and clinical considerations relating to the clinical trial design that may be relevant to the determination of safety and effectiveness for these devices.
|Location:||Hilton Gaithersburg MD||Related News Links:||Not Available|
- Antimicrobial Drugs AdComm
Meeting Date: 1/11/18-1/11/18
The committee will discuss new drug application (NDA) 210693, ciprofloxacin dispersion for inhalation, sponsored by Aradigm Corp., for the proposed indication of treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.
|Location:||College Park Marriott Hotel and Conference Center Chesapeake Ballroom 3501 University Blvd. East Hyattsville, MD 20783||Related News Links:||Not Available|
- Bone, Reproductive and Urologic Drugs AdComm
Meeting Date: 1/9/18-1/10/18
The committee will discuss new drug application (NDA) 206089, oral testosterone undecanoate capsules, submitted by Clarus Therapeutics, for the proposed indication of testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). The committee will discuss new drug application (NDA) 208088, oral testosterone undecanoate capsules, submitted by Lipocine Inc. for the proposed indication of testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
|Location:||Related News Links:||Not Available|