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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
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
