Buy 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 (purchase glucophagemetformin hydrochloride extended-release tablets,generic glucophage fda aproved). 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. At least 12 generic drug makers were poised to divvy up the $1.8-billion pie of metformin, the generic equivalent of Bristol-Myers Squibb’s type 2 diabetes drug Glucophage, as of Feb. 4.Alpharma, Barr Laboratories, Eon Labs, Genpharm, Ivax, Mylan Laboratories, Pharmaceutical Resources, Teva Pharmaceuticals and several others are among the generic drug makers who will begin launching generic Glucophage.BMS, which had held on tenaciously to the Glucophage patent, recently exhausted its last legal option.The bevvy of virtually simultaneous metformin approvals may cause a generic price war. Responding to a Drug Store News inquiry, the FDA confirmed that, while several metformin approvals were issued on the same day, no generic drug maker received the lucrative 180-day period of sales exclusivity.