FDA Pipeline Preview, November 2011 (NuPathe, Teva, Wilex, Atox Bio, Biovest, Dr. Reddy's Laboratories, Apotex, Par Pharmaceuticals)
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)
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
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