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Tentative Approval for Generic Glucophage Withdrawn by FDA
The Company stated that it had planned to launch its generic product by the end of its fiscal 2004, ending June 30, 2004, but had not included any contribution from the product in its earnings guidance for fiscal 2004. Accordingly, the withdrawal has no impact on the Company's earnings guidance for fiscal 2004.
On October 31, 2003 the Company announced that it had received a tentative approval for its generic version of Bristol-Myers Squibb's Glucophage XR (Metformin Hydrochloride extended- release tablets) 500 mg Tablet and that the Company anticipated 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.
Source: Barr Pharmaceuticals, Inc.