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Tentative Approval for Generic Glucophage Withdrawn by FDA

WOODCLIFF LAKE, N.J., Jan. 9 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its wholly-owned subsidiary, Barr Laboratories, Inc., has received notification from the U.S. Food and Drug Administration (FDA) that its tentative approval for its generic version of Bristol-Myers Squibb's Glucophage(R) XR (Metformin Hydrochloride extended- release tablets) 500 mg Tablet has been withdrawn. The FDA's letter stated the withdrawal is based solely on concerns regarding the raw material supplied to Barr by a third party and used to manufacture the Company's submission batch. The Company is committed to obtaining approval of this product and is evaluating its options, including the use of a new raw material supplier.

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.

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