FDA Advisory Committee Calendar
Posted 08 January 2019 | By
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11 January – Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee
The committees will discuss supplemental new drug application (sNDA) 021-856, ULORIC (febuxostat) tablets, sponsored by Takeda Pharmaceuticals, which includes the results from the postmarketing safety trial required by FDA to evaluate the cardiovascular safety of febuxostat, entitled “Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES).” Febuxostat is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout. The committees' discussion will include the results from the CARES trial, the benefit risk assessment of febuxostat, and potential regulatory actions.
16 January – Bone, Reproductive and Urologic Drugs Advisory Committee
The committee will discuss biologics license application 761062, romosozumab injection, submitted by Amgen, for the proposed indication of treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant of other available osteoporosis therapy.
17 January – Endocrinologic and Metabolic Drugs Advisory Committee
The committee will discuss new drug application 210934 for sotagliflozin oral tablet, sponsored by Sanofi-Aventis U.S., LLC, for the proposed indication: Adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.