FDA News

Abraxis BioScience Receives FDA Tentative Approval for Fosphenytoin Sodium Injection, USP

(April 19, 2007)-- Abraxis BioScience, an integrated, global biopharmaceutical company, announced that it has received a tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fosphenytoin Sodium Injection, 100 mg, 2 mL and 500 mg, 10 mL vials, USP, the generic equivalent of Pfizer’s Cerebyx. According to IMS, sales in 2006 of fosphenytoin sodium injection in the United States exceeded $73 million. The company expects to receive final approval for, and commence marketing of, fosphenytoin sodium injection upon patent expiration. The product is AP rated, preservative-free and latex-free.

Fosphenytoin Sodium Injection is indicated for short-term parenteral administration when other means of phenytoin administration are unavailable, inappropriate, or deemed less advantageous. The safety and effectiveness of Fosphenytoin Sodium Injection in this use has not been systematically evaluated for more than five days.

Fosphenytoin Sodium Injection can be used for the control of generalized convulsive status epilepticus and prevention and treatment of seizures occurring during neurosurgery. It can also be substituted, short-term, for oral phenytoin.

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