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APP Receives Tentative Approval for Granisetron Hydrochloride Injection, USP |
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12 Sep 2007 |
Abraxis Pharmaceutical Products today announced that it has received tentative approval from the FDA of its Abbreviated New Drug Application (ANDA) for Granisetron Hydrochloride Injection, 1 mg/mL, 1 mL vials, USP, the generic equivalent of Hoffmann-La Roche's Kytril(R) Injection
SCHAUMBURG, IL, USA | September 11, 2007 | Abraxis Pharmaceutical Products (APP), the hospital-based business of Abraxis BioScience, Inc. (NASDAQ:ABBI), today announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Granisetron Hydrochloride Injection, 1 mg/mL, 1 mL vials, USP, the generic equivalent of Hoffmann-La Roche's Kytril(R) Injection. According to IMS, sales of granisetron hydrochloride injection for 2006 in the United States exceeded $43 million. APP expects to receive final approval for, and commence marketing of, granisetron hydrochloride injection upon patent expiration in December 2007. The product is AP-rated, preservative and latex-free, as well as bar-coded.
Granisetron Hydrochloride Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of chemotherapy including high-dose cisplatin and radiation therapy for the treatment of cancer. Granisetron Hydrochloride Injection is also indicated for the prevention of postoperative nausea and vomiting.
About Abraxis Pharmaceutical Partners (APP)
APP is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on hospital-based anti-infective, critical care, oncology and anesthetic/analgesic markets. With products totaling over 400 dosage forms and a market-leading pipeline, APP offers patients and healthcare providers one of the broadest portfolios of injectable products in the United States. On July 2, 2007, Abraxis BioScience (Nasdaq: ABBI) announced that its board of directors had approved the separation of APP and its proprietary business into two independent public companies, subject to the satisfaction of various closing conditions, to enable the two business units to concentrate on their core competencies and compete more effectively in their respective marketplaces. APP is headquartered in Schaumburg, IL. For more information about APP, visit www.appdrugs.com.
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.
SOURCE: Abraxis BioScience, Inc. |
