Abraxis BioScience Receives FDA Tentative Approval for Fosphenytoin Sodium Injection, USP.LOS ANGELES -- Abraxis BioScience, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ABBI Advanced Breast Biopsy Instrument (ABBI) Uses a rotating circular knife and thin heated electrical wire to remove a large cylinder of abnormal breast tissue. Mentioned in: Fibrocystic Condition of the Breast ), an integrated, global biopharmaceutical company, today announced that it has received a tentative approval from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA) for Fosphenytoin Sodium Injection, 100 mg, 2 mL and 500 mg, 10 mL vials, USP USP - unique sales point , the generic equivalent of Pfizer's Cerebyx([R]). According to IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. , 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 phenytoin /phen·y·to·in/ (fen´i-toin?) an anticonvulsant used in the control of various kinds of epilepsy and of seizures associated with neurosurgery. phen·y·to·in n. 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([R]), 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([R]) is a registered trademark of Pfizer Inc. |
|
|||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion