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Recent FDA action (through December 2012) related to, Rabeprazole sodium delayed-release sprinkle capsules, CXA-201, CB-215, Buprenorphine subdermal implant, LX1033, ISIS-TTR Rx, Digoxin Immune Fab, Glucagon, AAV1-FS344, Trans sodium crocetinate, Betamethasone valerate foam 0.12%

Priority review

  • Rabeprazole sodium (AcipHex, Eisai) delayed-release sprinkle capsules (5 mg and 10 mg) for treatment of gastroesophageal reflux disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children aged 1 to 11 years.

  • CXA-201 and CB-315 (Cubist) antibiotics. CXA-201 is being developed as a first-line intravenous treatment for urinary tract infections and complicated intra-abdominal infections. CB-315 is intended for Clostridium difficile-associated diarrhea.

  • Buprenorphine (Probuphine, Titan Pharmaceuticals) subdermal implant formulation for the treatment of adult patients with opioid dependence.

Fast-track designations

  • LX1033 (Lexicon Pharmaceuticals), an orally-delivered small-molecule candidate, for the treatment of diarrhea-predominant irritable bowel syndrome.

  • ISIS-TTR Rx (Isis Pharma/GlaxoSmithKline) for the treatment of familial amyloid polyneuropathy, or FAP.

  • Digoxin Immune Fab (Glenveigh Medical) to treat severe preeclampsia.

Orphan drug designations

  • Glucagon (Biodel) for the prevention of hypoglycemia in the congenital hyperinsulinism population.

  • AAV1-FS344 (Milo Biotechnology), a gene therapy-delivered myostatin inhibitor that increases muscle strength, for the treatment of Duchenne and Becker muscular dystrophy.

  • Trans sodium crocetinate (Diffusion Pharmaceuticals) for the treatment of metastatic brain cancer.

First-time generic approval

Betamethasone valerate foam 0.12% (equiv to Luxiq Foam)
perrigo and cobrek pharmaceuticals

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