Abraxis BioScience Receives FDA Approval for Oxytocin Injection 10 USP Units/mL in a 30 mL Vial
07 August 2007 - 10:00PM
Business Wire
Abraxis BioScience, Inc. (NASDAQ: ABBI), 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� 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.
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