APP Pharmaceuticals Receives FDA Approval for Caffeine Citrate Oral Solution, USP

SCHAUMBURG, Ill.--(BUSINESS WIRE)--APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Caffeine Citrate Oral Solution, USP, 20 mg/ml, the equivalent of Bedford Laboratories’ Cafcit® Oral Solution. APP’s Caffeine Citrate Oral Solution is AP-rated, preservative and latex-free, and bar-coded at the individual unit-of-use. According to 2007 IMS data, annualized sales of Caffeine Citrate Oral Solution were approximately $12.6 million.
MORE ON THIS TOPIC