Andrx Files ANDA for Depakote
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--March 3, 2000--ANDRX CORPORATION (Nasdaq:ADRX - news) today announced that the United States Food and Drug Administration (FDA) has accepted its Abbreviated New Drug Application (ANDA) submission for a bioequivalent version of Depakote©. Marketed by Abbott Laboratories, Inc. for the treatment of epilepsy, Depakote© reported 1999 sales in the U.S. of nearly $700 million.
Andrx believes that its formulation filed under Paragraph IV of the Hatch-Waxman amendments does not infringe the patents that have been listed in the FDA's Orange Book as covering this product.
Alan P. Cohen, Co-Chairman and Chief Executive Officer of Andrx, said, ``This is the eighth ANDA that Andrx now has on file with the FDA to bring our bioequivalent products to market. The brand versions of these products had approximately $6 billion in 1999 U.S. sales.'
Andrx is engaged in the formulation and commercialization of oral controlled-release pharmaceuticals utilizing its proprietary drug delivery technologies. In its ANDA program, the Company is developing generic versions of selected high sales volume controlled-release brand name pharmaceuticals. In its NDA program, the Company is developing its own brand name formulations of certain existing drugs that it believes may be improved by the application of the Company's drug delivery technologies. The Company also markets and distributes pharmaceutical products manufactured by third parties and, through its Cybear, Inc. subsidiary (NASDAQ: CYBA - news), is developing internet-based software and applications for the healthcare industry.
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, words such as ``may', ``will', ``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 risks and uncertainties, including those risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission. |
