FDA News

Abraxis BioScience's Caffeine Citrate Injection USP, 20 mg/mL gets FDA Approval

(Aug 03, 2007)-- Abraxis BioScience, an integrated, global biopharmaceutical company, 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 Abbreviated New Drug Application (ANDA) for Caffeine Citrate injection, USP, 20 mg/mL, the generic equivalent of Cafcit Injection manufactured by Mead Johnson and Company. According to IMS 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 (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.

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