Mylan Pharmaceuticals Inc. received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Balsalazide Disodium Capsules, 750 mg.
Balsalazide Disodium Capsules are the generic version of Salix Pharmaceuticals' Colazal Capsules, which had US sales of approximately $130.9 million for the 12 months ending Sept. 30, 2007.
Mylan Inc. is one of the world's leading quality generic and specialty pharmaceutical companies. The company offers one of the industry's broadest and highest quality product portfolios, a robust product pipeline and a global commercial footprint through operations in more than 90 countries.