Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Topic	Advisory Committee	Date	Details
Repros Therapeutics' enclomiphene citrate 12.5 mg and 25 mg capsules for the treatment of secondary hypogonadism in fertile men younger than 60 years of age with a Body Mass Index over 25 kg/m^2	Bone, Reproductive and Urologic Drugs	Nov. 3 CANCELLED	Meeting notice (Also see "Repros At A Loss After FDA Abruptly Cancels Enclomiphene Panel Review" - Pink Sheet, 29 Oct, 2015.)
Risks and benefits of systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions	Antimicrobial Drugs, and Drug Safety and Risk Management	Nov. 5	Meeting notice
Organon USA's (Merck) sugammadex sodium injection for reversal of moderate or deep neuromuscular blockade induced by rocuronium or vecuronium	Anesthetic and Analgesic Drug Products	Nov. 6	Meeting notice
Considerations for evaluation of the safety and effectiveness of vaccines administered to pregnant women to protect the infant	Vaccines and Related Biological Products	Nov. 13	Meeting notice
Telesta Therapeutics' Mycobacterium phlei cell wall-nucleic acid complex for treatment of non-muscle invasive bladder cancer at high risk of recurrence or progression in adults who failed prior Bacillus Calmette-Guérin (BCG) immunotherapy, e.g., in patients who are BCG-refractory or BCG-relapsing	Cellular, Tissue and Gene Therapies, and Oncologic Drugs	Nov. 18	Meeting notice (Also see "Telesta's Bladder Cancer Therapy To Face Questions On Evidence Adequacy" - Pink Sheet, 25 Sep, 2015.)
Updates from the CERSI Evaluation and ORA Food Emergency Response Network Evaluation subcommittees; update on scope of FDA’s involvement in precision medicine; overview of specific health informatics initiatives, including precisionFDA, Open FDA and Chillax; update on FDA’s laboratory safety initiative; presentation by an FY 2014 Scientific Achievement Awards recipient	Science Board	Nov. 18	Meeting notice
Potential pediatric development plans for two products in various stages of development for adult cancer indications: AbbVie's ABT-414 and Eisai's lenvatinib	Oncologic Drugs' Pediatric Oncology Subcommittee	Nov. 19	Meeting notice
BioMarin's drisapersen for 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	Peripheral and Central Nervous System Drugs	Nov. 24	Meeting notice (Also see "Duchenne Muscular Dystrophy Approval Race: BioMarin Pulls Back Into Lead" - Pink Sheet, 14 Oct, 2015.)
Fabre-Kramer's gepirone hydrochloride extended-release tablets for major depressive disorder	Psychopharmacologic Drugs	Dec. 1	Meeting notice (Also see "Is Fabre-Kramer’s Gepirone Antidepressant Rising From The Dead After 8 Years?" - Pink Sheet, 8 Sep, 2015.)
Teva's reslizumab for injection to reduce exacerbations, relieve symptoms and improve lung function in adults and adolescents 12 years and older with asthma and elevated blood eosinophils who are inadequately controlled on inhaled corticosteroids	Pulmonary-Allergy Drugs	Dec. 9	Meeting notice
Safety of codeine in children 18 years and younger, with a focus on risk of serious adverse events, such as respiratory depression and death, including reports in children who are CYP2D6 ultra-rapid metabolizers; committees will discuss whether codeine use in children should be further restricted and whether codeine should be available through the OTC Drug Monograph	Pulmonary-Allergy Drugs, and Drug Safety and Risk Management	Dec. 10	Meeting notice