APP Pharmaceuticals, Inc., a leading manufacturer of multi-source and branded injectable pharmaceutical products, announced that it has received approval from the US 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.
Caffeine citrate oral solution is indicated for the short term treatment of apnea of premature infants, an APP press release stated.
APP is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on oncology, anti-infective and critical care markets. The company is one of the largest producers of injectables, with more than 100 generic products in more than 400 dosage formulations.