Abraxis BioScience Receives FDA Approval for Oxytocin Injection 10 USP Units/mL in a 30 mL Vial
Business Wire
Aug. 7 -- Abraxis BioScience, Inc., an integrated, global biopharmaceutical company, today announced that its hospital-based products business, Abraxis Pharmaceutical Products (APP), has received approval from the U.S. Food and Drug Administration (FDA) for its Supplemental New Drug Application (sNDA) for Oxytocin Injection, USP, 30 mL.
As the market leader, APP currently manufactures and distributes Oxytocin in 1mL and 10 mL vials, and this unique 30mL code is expected to further secure APP's position. The company will distribute this larger, more convenient size in multi-dose vials with latex-free stoppers and expects to commence marketing of this product in the third quarter of 2007. According to IMS data, annual sales in 2006 of this product across all distributors and dosage forms were approximately $33 million.
Oxytocin Injection is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is also indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
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 over 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 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.