Abraxis BioScience Receives FDA Approval for Caffeine Citrate Injection USP, 20 mg/mL
03 August 2007 - 12:55AM
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 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
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