APP Receives Two FDA Approvals For Fludarabine Phosphate

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Lymphoma / Leukemia / Myeloma
Article Date: 18 Oct 2007 - 3:00 PDT

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Abraxis Pharmaceutical Products (APP), the hospital-based business of Abraxis BioScience, Inc. (NASDAQ:ABBI), announced two approvals from U.S. Food and Drug Administration (FDA) to market the liquid and lyophilized versions of Fludarabine phosphate. The lyophilized version of fludarabine, which is the generic equivalent of Fludara® (fludarabine phosphate) for injection distributed by Bayer HealthCare Pharmaceuticals Inc., will be packaged in 50 mg/2mL single-dose vials. The liquid version of fludarabine, which is the equivalent of fludarabine phosphate for injection marketed by Teva Parenteral Medicines, Inc., will be packaged in a 50 mg single dose vial. According to IMS data, sales of these products across all dosage forms were approximately $15.5 million in 2006.

Fludarabine is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of fludarabine in previously untreated or non-refractory patients with CLL have not been established.

CLL is a common adult leukemia in the United States and occurs more often in men than in women, affecting people over 50 years of age. Fludarabine, which interferes with the process of leukemia cell growth, has been proven effective in clinical trials among patients who did not benefit from chemotherapy with alkylating agents.

APP manufactures and markets one of the most comprehensive injectable portfolios of products to the U.S. hospital-based market. The current injectable portfolio is comprised of anti-infectives, critical care, oncology and anesthetic/analgesic products totaling over 400 dosage forms. Including those ANDAs pending with the FDA, APP currently has approximately 60 product candidates in various stages of development.

About Abraxis BioScience, Inc.

Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company's hospital and clinic-based business, Abraxis Pharmaceutical Products (APP), is expected to be known as APP Pharmaceuticals subsequent to the close of the previously announced separation of the proprietary business from Abraxis. APP develops, manufactures and markets one of the broadest portfolios of injectable products in the industry. Abraxis trades on the Nasdaq Global Market under the symbol ABBI. For more information about the company and its products, please visit http://www.abraxisbio.com or http://www.appdrugs.com.

Fludara® is a registered trademark of Bayer HealthCare Pharmaceuticals Inc.

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