Abraxis BioScience Receives Final Approval for Fosphenytoin Sodium Injection, USP
06 Agosto 2007 - 10:15PM
Business Wire
Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global
biopharmaceutical company, today announced final 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 commence marketing of fosphenytoin sodium
injection in August 2007. 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 the 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� 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.
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