Corporation 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 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.

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.