Andrx Files ANDA for Claritin D-24
Tuesday February 15, 8:35 am Eastern Time
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Feb. 15, 2000--ANDRX CORPORATION (Nasdaq:ADRX - news) today announced that the United States Food and Drug Administration has accepted its Abbreviated New Drug Application (ANDA) submission for a bioequivalent version of Claritin D-24©. Marketed by Schering Plough Corporation for the treatment of allergies, Claritin D-24© is a once-a-day antihistamine, with reported 1999 U.S. sales in excess of $350 million.
Andrx believes that it is the first company to have an ANDA for Claritin D-24© accepted for filing by the FDA under Paragraph IV of the Hatch-Waxman Amendments. Accordingly, once FDA approval is received, Andrx' bioequivalent version should be entitled to 180 days of marketing exclusivity. Andrx believes that this filing is the seventh time that it has been the first company to file an ANDA to commercialize bioequivalent versions of controlled-release products prior to the expiration of patent protection. Andrx is presently in litigation with AstraZeneca PLC, Elan Corporation PLC, Biovail Corporation International, and Glaxo Wellcome Inc. for the ability to market bioequivalent versions of Prilosec© (the largest selling drug in the U.S. and throughout the world), Naprelan©, Tiazac©, Wellbutrin© SR and Zyban©, respectively.
Dr. Chih-Ming Chen, Co-Chairman and Chief Scientific Officer of Andrx, said, ``This is yet another demonstration of our great R&D team's ability to create a new product without infringing patents of the innovator. Andrx currently has seven ANDAs awaiting FDA approval for controlled-release products which address annual U.S. brand sales of approximately $5 billion. Our new four-fold-larger R&D facility will be ready by mid-year, which will allow us to further expand our brand (NDA) and bioequivalent (ANDA) R&D programs.'
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. |
