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New Diabetes Drug: Andrx Gains FDA Tentative Approval for Generic 10 mg Glucotrol XL

  [ 21 votes ]   [ Discuss This Article ]
www.ProHealth.com • August 27, 2003


FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Aug. 26, 2003--Andrx Corporation (Nasdaq:ADRX) today announced that the United States Food and Drug Administration ("FDA") has tentatively approved the Abbreviated New Drug Application ("ANDA") for its 10 mg glipizide extended release tablets, a bioequivalent version of Pfizer Inc.'s ("Pfizer") Glucotrol(R) XL tablets. Indicated for the treatment of Type II diabetes, the 10mg strength of Glucotrol XL had $217 million of brand sales in 2002, according to IMS data.

The 30-month stay of FDA regulatory approval applicable to this ANDA will not expire until November 2003, and the patent infringement litigation pending between Andrx, Pfizer and Alza Corporation with respect to the three Glucotrol XL strengths for which Andrx has pending ANDAs is continuing. Andrx's ANDA for 5 mg and 2.5 mg Glucotrol XL was submitted after its ANDA for the 10mg strength, and has not been tentatively approved by the FDA. Though Andrx believes that it was the first to file an ANDA for 10 mg Glucotrol XL, the tentative approval letter issued by the FDA does not address the issues relating to the 180 day market exclusivity period for this product.

About Andrx

Andrx Corporation develops and commercializes: bioequivalent versions of controlled-release brand name pharmaceuticals, using its proprietary drug delivery technologies; bioequivalent versions of specialty, niche and immediate-release pharmaceutical products, including oral contraceptives; and brand name or proprietary controlled-release formulations of existing immediate-release or controlled-release drugs where it believes the application of Andrx's drug delivery technologies may improve the efficacy or other characteristics of those products. Andrx also has distribution operations, which purchase primarily generic pharmaceuticals manufactured by third parties and sell them primarily to independent pharmacies, pharmacy chains which do not maintain their own central warehousing facilities, pharmacy buying groups and, to a lesser extent, physicians' offices.

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 herein or which are otherwise made by or on behalf of the Company that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties, including but not limited to, the timing and outcome of litigation and future product launches; government regulation generally; competition; manufacturing capacities and output; commercial obstacles to the successful introduction of brand products generally; product liability claims; rising costs and availability of insurance, including product liability insurance; and the absence of certainty regarding the receipt of required regulatory approvals or the timing or terms of such approvals. Andrx Corporation is also subject to other risks detailed herein or detailed from time to time in its filings with the U.S. Securities and Exchange Commission, including, but not limited to, the Company's Annual Report on Form 10-K for the year ended December 31, 2002 and Forms 10-Q for the quarters ended March 31, 2003 and June 30, 2003.

This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com.

SOURCE: Andrx Corporation



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