Pharma Blog Watch

FDA is Grinch This Christmas (Eye on FDA)
The FDA has left a lump of coal in the stockings of several pharmaceutical companies, writes blogger Mark Senak. He discusses approvable letters the FDA issued to three companies, which need to be resolved before their drugs can be approved.

"New River Pharmaceuticals and Shire — A second approvable letter was issued to these two companies for a treatment for attention-deficit/hyperactivity disorder. The first approvable letter was issued on October 6, 2006, and the company speedily submitted a response on October 24, 2006. According to Yahoo Finance, the FDA is not requesting new studies.

"Allergan Receives Approvable Letter — Allergan of Irvine, California, announced an approvable letter for its product for Combigan, a treatment for patients with glaucoma experiencing elevated intraocular pressure. The release states that an additional confirmatory study is being requested by the agency and a quote from the executive vice president of R&D states that the study has already been under way.

"Generic Omeprazole Delayed — Perrigo announced that it received an approvable letter for a generic version of omeprazole. There was no word on the cause of the approvable letter or what conditions the FDA is seeking prior to approval. If eventually approved, however, the generic version of omeprazole, a compound now marketed by Procter & Gamble as Prilosec OTC, would be the first.