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Andrx Receives Final Approval for Generic Biaxin XL Filmtab 500mg.

Publication: Business Wire
Publication Date: 25-JUN-04
Format: Online - approximately 551 words
Delivery: Immediate Online Access

Article Excerpt
FORT LAUDERDALE, Fla. -- Andrx Corporation ("Andrx" or "Company") (Nasdaq:ADRX) today announced that the United States Food and Drug Administration ("FDA") has approved the Company's abbreviated new drug application ("ANDA") for Clarithromycin Extended-release Tablets, 500mg, an antibiotic which is bioequivalent to Abbott Laboratories Inc.'s Biaxin(R) XL Filmtab(R). The brand product had approximately $280 million of sales in 2003, according to IMS data. Andrx does not plan to launch its generic version of Biaxin XL Filmtab prior to the expiration of a...

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