Glucophage

Barr Laboratories announced that it received tentative approval from the Food and Drug Administration for its generic version of Bristol-Myers Squibb's Glucophage XR (metformin hydrochloride extended-release tablets). The company will launch the drug after the expiration of a 180-day generic exclusivity period granted under Hatch-Waxman provisions. The owner of that exclusivity period, however, remains in question.

Generic drug maker Alpharma brought legal action against the FDA after it granted first-to-file status and final approval to Ivax for its extended-release metformin product. A temporary restraining order was granted against the FDA pending a preliminary injunction hearing that was scheduled for Nov. 12.

Metformin hydrochloride extended-release tablets are indicated as adjunct therapy to diet and exercise to improve glycemic control in type 2 diabetics. The generic drugs will compete in a market with total annual sales of $462 million, according to IMS Health data for the 12 months ended in August.

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