Abraxis BioScience Receives FDA Approvals for Clindamycin Injection, USP
LOS ANGELES -- Abraxis BioScience, Inc., an integrated, global biopharmaceutical company, today announced that it has received two approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Clindamycin Injection, 300mg, 600mg, 900mg and 9g, USP, the generic equivalent of Pfizer's Cleocin® Phosphate Injection. According to IMS, sales in 2006 of clindamycin in the United States exceeded $16 million. The company will soon commence marketing clindamycin in 9g pharmacy bulk pack (PBP) and 300mg, 600mg and 900mg single-dose bar coded vials. The product is AP rated and latex-free.
Clindamycin Injection is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated for the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved penicillin-allergic patients or other patients for whom, in the judgment of the physician, penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
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.