New and Generic Drug Approvals

October 29, 2009

  • ARZERRA (ofatumumab) Injection, GlaxoSmithKine, Approval
  • Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules, Novartis Pharmaceuticals Corporation, Efficacy Supp. w/Clinical Data
  • Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules, Novartis Pharmaceuticals Corporation, Labeling Revision
  • Norpramin (desipramine hydrochloride) Tablets, Sanofi-Aventis US, Inc., Labeling Revision
  • Risperidone Orally Disintegrating Tablets, Par Pharmaceutical, Inc., New Strength