September a busy month for FDA
September is going to be busy for FDA staff as they manage an unusually large number of product-based advisory committee meetings. NDAs (or sNDAs) under consideration include:
Bristol-Myers Squibb’s rheumatoid arthritis drug Orencia (abatacept); Arthritis Drugs Advisory Committee Sept. 6.
Pfizer’s inhaled insulin Exubera and Bristol-Myers Squib’s Pargluva (muraglitazar) for type II diabetes mellitus; Endocrinologic & Metabolic Drugs Advisory Committee Sept. 8 and 9, respectively.
Genetech/OSI’s Tarceva (erlotinib) supplemental indication for pancreatic cancer and Abbott’s Xinlay (atrasentan) for metastatic hormone-refractory prostate cancer; Oncologic Drugs Advisory Committee Sept. 13.
Celgene’s Revlimid (lenalidomide) for MDS and GlaxoSmithKline’s Arranon (nelarabine) injection for acute lymphoblastic leukemia; Oncologic Drugs Advisory Committee Sept. 14.
That’s five NMEs and a novel protein formulation potentially sanctioned for launch in a single month. Not too shabby.
