APP gets US approval for generic Cafcit

The USA's APP Pharmaceuticals, a manufacturer of multi-source and branded injectable pharmaceutical products, has received approval from the Food and Drug Administration for its Abbreviated New Drug Application for caffeine citrate oral solution, USP, 20mg/ml, the equivalent of Bedford Laboratories' Cafcit Oral Solution.

APP says that its generic is preservative- and latex-free and bar-coded at the individual unit-of-use. According to 2007 IMS Health data, annualized US sales of caffeine citrate oral solution were approximately $12.6 million. The product is indicated for the short-term treatment of apnea of premature infants.

The Schaumburg, Illinois-based firm has also received US approval for its generic version of drug major Bristol-Myers Squibb's anti-neoplasm drug Blenoxane (bleomycin sulfate). The injectable palliative treatment has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: squamous cell carcinoma, lymphomas, testicular carcinoma and malignant pleural effusion. According to 2007 IMS data, annual sales of bleomycin sulfate in the USA exceeded $7.2 million.