Abraxis BioScience Receives FDA Approval for Caffeine Citrate Injection USP, 20 mg/mL.LOS ANGELES -- Abraxis BioScience, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ABBI Advanced Breast Biopsy Instrument (ABBI) Uses a rotating circular knife and thin heated electrical wire to remove a large cylinder of abnormal breast tissue. Mentioned in: Fibrocystic Condition of the Breast ), 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA) for Caffeine Citrate injection, USP USP - unique sales point , 20 mg/mL, the generic equivalent of Cafcit([R]) Injection manufactured by Mead Johnson and Company. According to IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. data, annual sales in 2006 of this product across all distributors and dosage forms were approximately $16 million. APP will package this product in 60 mg/3mL single-use vials and expects to commence marketing of this product immediately. Caffeine Citrate Injection is indicated for the short term treatment of apnea of prematurity Apnea of prematurity is defined as cessation of breathing by a premature infant that lasts for more than 15 seconds and/or is accompanied by hypoxia or bradycardia. Apnea is traditionally classified as either obstructive, central, or mixed. (AOP) in infants between 28 and <33 weeks gestational age. AOP is a condition in which cessation of breathing in pre-term infants can cause dangerously low levels of blood oxygen. 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. |
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