FDA Tentatively Approves ANDRX ANDA for Naprelan
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--March 21, 2000--Andrx Corporation (Nasdaq:ADRX - news) today announced that the United States Food and Drug Administration (FDA) has tentatively approved the Abbreviated New Drug Application (ANDA) Andrx filed for a bioequivalent version of Naprelan©. Marketed by the Elan Corporation Plc., Naprelan© (Naproxen Sodium Extended-release Tablets) is used in the treatment of arthritis. Total U.S. brand sales for Naprelan© were approximately $50 million in 1999.
Andrx's bioequivalent version of Naprelan© is the subject of patent infringement litigation pending in the US District Court for the Southern District of Florida. The trial of this matter is presently scheduled to begin in April, although the court could grant Andrx's motions for summary judgment before that date. As a result of this litigation and other factors, it is uncertain when Andrx will be able to commence selling this product.
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 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.
Contact: Angelo C. Malahias, Vice President and Chief Financial Officer of Andrx Corporation, 4001 S.W. 47th Avenue, Fort Lauderdale, Florida 33314, 954-584-0300. This release and additional information about Andrx Corporation are also available on the Internet at: andrx.com
--------------------------------------------------------------------------------
Contact:
Andrx Corporation, Fort Lauderdale
Angelo C. Malahias, Vice President and
Chief Financial Officer, 954/584-0300 |
