Recent And Upcoming FDA Advisory Committee Meetings

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

Topics	Advisory Committee	Date	Details
Celltrion's CT-P10, a proposed biosimilar to Genentech's Rituxan (rituximab), in three non-Hodgkin's lymphoma indications	Oncologic Drugs	Oct. 10	Meeting notice (Also see "Celltrion’s Rituximab Biosimilar Has Easy US FDA Panel Ride Despite Questions About Narrow Label" - Pink Sheet, 10 Oct, 2018.)
Trevena's oliceridine 1 mg/mL injection for management of moderate to severe acute pain in adult patients for whom an intravenous opioid is warranted	Anesthetic and Analgesic Drug Products	Oct. 11	Meeting notice (Also see "Trevena's IV Opioid Not Quite 'Ready for Primetime,' US FDA Panel Concludes " - Pink Sheet, 11 Oct, 2018.)
AcelRx Pharmaceuticals' sufentanil sublingual tablets, for management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting	Anesthetic and Analgesic Drug Products	Oct. 12	Meeting notice (Also see "AcelRx's Sublingual Opioid Dsuvia Brings Unique Risk To Advisory Panel: Dropped Tablets" - Pink Sheet, 10 Oct, 2018.)
Sloan Pharma's Zelnorm (tegaserod maleate) for treatment of women with irritable bowel syndrome with constipation who do not have a history of cardiovascular ischemic disease and do not have more than one risk factor for CV disease	Gastrointestinal Drugs/Drug Safety and Risk Management	Oct. 17	Meeting notice
Shire's prucalopride for treatment of chronic idiopathic constipation in adults	Gastrointestinal Drugs	Oct. 18	Meeting notice
Cardiovascular risk assessment for drugs and biologics to treat type 2 diabetes	Endocrinologic and Metabolic Drugs	Oct. 24-25	Meeting notice
Alkermes' buprenorphine/samidorphan sublingual tablets for adjunctive treatment of major depressive disorder	Psychopharmacologic Drugs/Drug Safety and Risk Management	Nov. 1	Meeting notice
Sage Therapeutics' brexanolone 5mg/mL intravenous injection for postpartum depression	Psychopharmacologic Drugs/Drug Safety and Risk Management	Nov. 2	Meeting notice
Overview of the research program in the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review	Vaccines and Related Biological Products	Nov. 8	Meeting notice
SpecGx Inc.'s oxycodone immediate-release tablets, intended to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse, for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate	Anesthetic and Analgesic Drug Products/Drug Safety and Risk Management	Nov. 14	Meeting notice
Assessment of opioid analgesic sparing outcomes in clinical trials of acute pain	Anesthetic and Analgesic Drug Products	Nov. 15	Meeting notice