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cancer weekly

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Drug Development



Abbreviated new drug application for antitumor cancer drug granted by U.S. FDA



December 14th, 2004

SuperGen, Inc. (SUPG) 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 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 and is indicated as treatment for a variety of cancers.

Based in Dublin, California, SuperGen is a pharmaceutical...


Source: cancer weekly (2004-12-14)

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