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Generic Cancer Drug Cleared for Marketing
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.