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Generic Cancer Drug Cleared for Marketing

DUBLIN, Calif., Nov 15, 2004 /PRNewswire-FirstCall via COMTEX/ -- SuperGen, Inc. (Nasdaq: SUPG) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Paclitaxel Injection, 6 mg/mL, packaged in 30 mg/5 mL and 100 mg/16.7 mL multiple-dose vials.

Paclitaxel belongs to the group of medicines called antineoplastics. The drug is equivalent to Bristol-Myers Squibb's Taxol(R) Injection; an antitumor agent that has become one of the most widely used anti-cancer products.

Paclitaxel Injection's approved indication is identical to Taxol(R) and is indicated as treatment for a variety of cancers.

"FDA approval of our ANDA to market Paclitaxel in the U.S. is a significant accomplishment for SuperGen," stated James Manuso, Ph.D., President and Chief Executive Officer. "We are currently in discussions with several U.S. multi-source generic manufacturers specializing in oncology and hope to complete a marketing and distribution licensing agreement during the first half of 2005."

Source: SuperGen, Inc.

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