FDA FY2012 Drug Approvals Equal FY2011 Mark

by McDonnell Boehnen Hulbert & Berghoff LLP

FDA ReportLast month, the U.S. Food and Drug Administration released its annual report on innovative drug approvals, noting that the agency approved 35 novel medicines in FY 2012.  The 35 approvals equaled the number of approvals for FY 2011, and marked the highest number of approvals since the FDA approved 36 new drugs in FY 2004.  According to the report on FY 2012 Innovative Drug Approvals, ten of the 35 new drugs were approved for the treatment of cancer, two represent advances in personalized medicine, and nine new drugs were approved for the treatment of orphan diseases.  The report notes that the term "drugs" is intended to include products approved by both the FDA's Center for Drug Evaluation and Research (CDER), which reviews New Drug Applications (NDAs) for pharmaceuticals, and the agency's Center for Biologics Evaluation and Research (CBER), which reviews biological therapeutic agents.

The report indicated that most of the new drugs were approved for U.S. patients before the drugs were available in other countries.  In particular, of the 32 new drugs for which comparisons could made with approvals in other countries, 75% (24) were first approved in the U.S.  The FDA was able to achieve such results by approving 77% of the 35 new drugs on the first cycle of review, without requiring additional information that would have lengthened the approval time.

The 35 new drugs that were approved in FY 2012 include the following:

• AMYVID (florbetapir F18) - Avid Radio-pharmaceuticals, Inc.
• AUBAGIO (teriflunomide) - Sanofi-Aventis, U.S., LLC
• BElVIQ (lorcaserin hydrochloride) - Arena Pharmaceuticals, Inc.
• BOSULIF (bosutinib) - Pfizer Inc.
• CHOLINE C 11 - Mayo Clinic PET Radiochemistry Facility
• ELELYSO (taliglucerase alfa) - Protalix Biotherapeutics Inc.
• ERIVEDGE (vismodegib) - Genentech, Inc.
• ERWINAZE (asparaginase erwinia chrysanthemi) - EUSA Pharma (USA), Inc.
• EYLEA (aflibercept) - Regeneron Pharmaceuticals, Inc.
• FERRIPROX (deferiprone) - Apopharma, Inc.
• GINTUIT (allogeneic cultured keratinocytes and fibroblasts in bovine collagen) - Organogenesis, Inc.
• HEMACORD (hemapoietic progenitor cells, cord (HPC-C) - New York Blood Center, Inc.
• HPC, Cord Blood (hemapoietic progenitor cells, cord (HPC-C) - Clinimmune Labs
• INLYTA (axitinib) - Pfizer, Inc.
• JAKAFI (ruxolitinib) - Incyte Corp.
• KALYDECO (ivacaftor) - Vertex Pharmaceuticals, Inc.
• KYPROLIS (carfilzomib) - Onyx Pharmaceuticals, Inc.
• LINZESS (linaclotide) - Forest Laboratories, Inc.
• MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) - GlaxoSmithKline Biologicals
• MYRBERTIQ (mirabegron) - Astellas Pharma Global Development, Inc.
• NEUTROVAL (tbo-filgrastim) - Sicor Biotech UAB
• OMONTYS (peginesatide) - Affymax, Inc.
• ONFI (clobazam) - Lundbeck, Inc.
• PERJETA (pertuzumab) - Genentech, Inc.
• PICATO (ingenol mebutate) - Leo Pharma AS
• PREPOPIK (sodium picosulfate, magnesium oxide, citric acid) - Ferring Pharmaceuticals
• STIVARGA (regorafenib) - Bayer Healthcare Pharmaceuticals, Inc.
• STENDRA (avanafil) - Vivus Inc.
• STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) - Gilead Sciences, Inc.
• SURFAXIN (lucinactant) - Discovery Laboratories, Inc.
• TUDORZA PRESSAIR (aclidinium bromide) - Forest Laboratories, Inc.
• VORAXAZE (glucarpidase) - BTG international, Inc.
• XTANDI (enzalutamide) - Medivation, Inc.
• ZALTRAP (ziv-aflibercept) - Sanofi-Aventis U.S., LLC
• ZIOPTAN (tafluprost) - Merck Sharp and Dohme Corp.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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