Recent FDA action (through October 2011) related to golimumab expanded label, meningococcal and Hib combination vaccine, desvenlafaxine, rivaroxaban anticoagulant, deferiprone oral iron chelator, glucarpidase experimental treatment, doxidopa, QLT091001, NP-001,cyclophosphamide, resminostat oral pan HDAC inhibitor, TXA127
■ Transdermal sumatriptan migraine patch (Zelrix, NuPathe) for the treatment of migraine. The rejection was based on FDA's belief that the company provided insufficient data to support a migraine indication. The concerns are believed to be related to the safety of the single-use patch, based on questions FDA had regarding sumatriptan's chemical make-up and manufacturing. NuPathe stated in a press release that it will soon be able to provide the FDA with the additional information it is requesting, and may conduct additional studies as well.
Not recommended for approval
■ Rencarex (Wilex) for the adjuvant treatment of patients with non-metastatic clear cell renal cell carcinoma.
Orphan drug designations
■ AB103 (Atox Bio) for the treatment of necrotizing soft-tissue infections.
■ Personalized cancer vaccine (Biovest) for the treatment of Waldenstrom's macroglobulinemia.
■ First-time generic approvals
Olanzapine tablets and olanzapine orally disintegrating tablets (equiv to Zyprexa and Zyprexa Zydus, respectively)
DR. REDDY'S LABORATORIES AND TEVA (OLANZAPINE TABLETS); APOTEX, DR. REDDY'S LABORATORIES, AND PAR PHARMACEUTICALS (OLANZAPINE ORALLY DISINTEGRATING TABLETS)