SuperGen Inc. has received approval from the US FDA for 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 anti-tumour 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.
"FDA approval of our ANDA to market Paclitaxel in the US is a significant accomplishment for SuperGen," stated James Manuso, president and CEO. "We are currently in discussions with several US multi-source generic manufacturers specializing in oncology and hope to complete a marketing and distribution licensing agreement during the first half of 2005," he added.