Obesity & Diabetes Week
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Glycemic Control
Tentative FDA approval granted for generic Glucophage
November 24th, 2003
Barr Laboratories, Inc., (BRL) announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Bristol-Myers Squibb's Glucophage XR (Metformin Hydrochloride extended-release tablets) 500 mg Tablet. The company anticipates launching its generic product following the expiration of another company's 180-day generic exclusivity period under the provisions of Hatch-Waxman. Metformin Hydrochloride extended-release tablets, as a monotherapy, are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Metformin Hydrochloride extended-release...
Source: Obesity & Diabetes Week (2003-11-24)
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