APP Pharmaceuticals, Inc, a leading manufacturer of multi-source and branded injectable pharmaceutical products has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Bleomycin Sulfate for Injection, USP

APP Pharmaceuticals, Inc, a leading manufacturer of multi-source and branded injectable pharmaceutical products has received approval from the U.S. 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.

APP is a specialty drug company –  which 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. APP, headquartered in Schaumburg, Illinois, has offices in Canada and manufacturing operations in Illinois, New York and Puerto Rico.

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.