APP Pharmaceuticals, Inc., a leading manufacturer of multi-source and branded injectable pharmaceutical products, has received approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for bleomycin sulfate for injection, USP, the equivalent of Bristol-Myers Squibb's Blenoxane.
APP's bleomycin sulfate is AP-rated, preservative and latex-free, and bar-coded at the individual unit-of-use. According to 2007 IMS data, sales of bleomycin sulfate exceeded $7.2 million.
Bleomycin sulfate for injection should be considered a palliative treatment. It 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.
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.