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Andrx Granted FDA Tentative Approval for Generic Glucophage XR.

Business Editors & Health/Medical Writers


ANDRX CORPORATION -- Andrx Group (Nasdaq:ADRX) today announced that the United States Food and Drug Administration (FDA) has tentatively approved the marketing of its Abbreviated New Drug Application (ANDA) for metformin hydrochloride extended release tablets. Metformin extended release is bioequivalent to Bristol-Myers Squibb Company's brand name product, Glucophage(R) XR, and is used in the treatment of Type 2 diabetes. Glucophage XR was launched in the fourth quarter of 2000, and its first full year sales in 2001 were $223 million, with $90 million of those sales in the fourth quarter of the year.

Andrx Chief Executive Officer and President, Elliot F. Hahn, Ph.D., commented: "Within eighteen months of the brand's launch, we formulated our product, submitted an ANDA and received FDA tentative approval for a generic version of Glucophage XR, which speaks volumes for the quality of our research and development team. We believe the exclusivity period for Glucophage XR expires at the end of 2003, and we look forward to launching our product at that time."

A tentative approval indicates that FDA has made an initial determination that the application for a generic drug satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed periods during which approval cannot be granted. A final approval is required for the applicant to market the generic drug.

Andrx Corporation is a specialty pharmaceutical company engaged in the formulation and commercialization of oral controlled-release generic and brand pharmaceuticals utilizing its proprietary drug delivery technologies.

Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained in this report that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, there can be no assurance as to when or whether the Andrx ANDA for Glucophage XR will receive final marketing approval from the FDA, and words such as "may," "will," "to," "expect," "plan," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative or other variations thereof or comparable terminology is intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties, including those risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission.

This release and additional information about Andrx Corporation are also available on the Internet at:
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Publication:Business Wire
Date:Apr 25, 2002
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