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