News | September 18, 2000

FDA approves generic Taxol

On September 15, IVAX Corp. (Miami) received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for paclitaxel 6 mg/mL injection (packaged in 30 mg/5 mL, 150 mg/25 mL, and 300 mg/50 mL multiple-dose vials). Indicated for the treatment of breast and ovarian cancer, IVAX's paclitaxel injection is the generic equivalent of Bristol-Myers Squibb Co.'s Taxol, estimated to have U.S. sales of $1.2 billion this year. IVAX' first-to-file position for this product entitles the company to 180 days of marketing exclusivity for generic paclitaxel. The product will be marketed through IVAX's wholly owned subsidiary, Zenith Goldline Pharmaceuticals Inc.

Neil Flanzraich, vice chairman and president of IVAX, said "Anyone who has followed IVAX' efforts to bring its generic version of Taxol to market in the United States knows IVAX has had to overcome a succession of disruptive and delaying tactics. We strongly believe the system must be changed to eliminate opportunities for abuse by those seeking to prevent or delay generic competition, and we will say more about that in the future. For the moment, we are pleased that this important victory will benefit the thousands of American women suffering from breast and ovarian cancer."

IVAX Corp., headquartered in Miami, is a holding company with subsidiaries engaged in the research, development, manufacturing, and marketing of branded and generic pharmaceuticals and veterinary and diagnostic products in the U.S. and international markets.

For more information, contact Jordan Siegel, VP and treasurer of IVAX, at 305-575-6043.

Edited by Angelo DePalma
Managing Editor, Pharmaceutical Online