FDA Pipeline Preview, November 2011 (NuPathe, Teva, Wilex, Atox Bio, Biovest, Dr. Reddy's Laboratories, Apotex, Par Pharmaceuticals)

November 1, 2011

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

Complete response

■ 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

Fast-track designation

■ 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)

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