Healthcare Industry News:  Abraxis BioScience 

Biopharmaceuticals Generics FDA

 News Release - April 19, 2007

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

LOS ANGELES--(HSMN NewsFeed)--Abraxis BioScience, Inc. (NASDAQ:ABBI ), an integrated, global biopharmaceutical company, today 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.

About Abraxis BioScience, Inc.

Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company develops, manufactures and markets one of the broadest portfolios of injectable products and leverages revolutionary technology such as its nab(TM) platform to discover and deliver breakthrough therapeutics that transform the treatment of cancer and other life-threatening diseases. The first FDA approved product to use this nab platform, ABRAXANE®, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the Nasdaq Global Market under the symbol ABBI. For more information about the company and its products, please visit www.abraxisbio.com.

Cerebyx® is a registered trademark of Pfizer Inc.


Source: Abraxis BioScience

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