Recent FDA action (through July 2012) related to, morphine and oxycodone Dual Opioid platform, MoxDuo, QRxPharma, apixaban, Eliquis, Bristol-Myers Squibb, RG1068, Repligen, Multi-Stem, Athersys, Rivaroxaban, Xarelto, Janssen, Ocriplasmin intravitreal injection, ThromboGenics, Regorafenib, Bayer, Onyx Pharmaceuticals, Pregabalin, Lyrica, Lupin, Diclofenac sodium and misoprostol, Arthrotec, Watson, Next Choice One Dose, Plan B One-Step
■ New Drug Application (NDA) for morphine and oxycodone Dual Opioid platform (MoxDuo, QRxPharma) for the treatment of moderate to severe acute pain. The company is presently considering its response to the requests for additional information with regard to the safety and effectiveness of MoxDuo and has been granted a meeting with FDA to clarify the steps required for approval.
■ A New Drug Application (NDA) for apixaban (Eliquis, Bristol-Myers Squibb) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The complete response letter (CRL) requests additional information on data management and verification from the ARISTOTLE trial. A company press release stated that Bristol-Myers Squibb and Pfizer will work closely with FDA on the appropriate next steps for the apixaban application. FDA has not requested that the companies complete any new studies. FDA and the companies are committed to working expeditiously to address the outstanding questions and move the application forward.
Orphan drug designations
■ Proprietary cell therapy (MultiStem, Athersys) for the treatment of Hurler's syndrome, also known as mucopolysaccharidosis type I or MPS-I.
■ Rivaroxaban (Xarelto, Janssen) for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and the long-term prevention of recurrent DVT and PE.
■ Ocriplasmin intravitreal injection, 2.5 mg/mL (ThromboGenics) for the treatment of symptomatic vitreomacular adhesion including macular hole.
■ Regorafenib (Bayer and Onyx Pharmaceuticals) for the treatment of patients with metastatic colorectal cancer.
First-time generic approvals
Pregabalin capsules in 25-mg, 50-mg, 75-mg, 100-mg, 150-mg, 200-mg, 225-mg, and 300-mg strengths (equiv to Lyrica)
Diclofenac sodium and misoprostol delayed-release tablets (equiv to Arthrotec)
Next Choice One Dose (levonorgestrel) tablets in 1.5-mg strength (equiv to Plan B One-Step)