Final FDA approval for generic version of antiretroviral Zerit capsules

Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received final approval from the U.S. Food and Drug Administration (FDA) on December 29, for its Abbreviated New Drug Application (ANDA) for Stavudine Capsules USP, 15 mg, 20 mg, 30 mg and 40 mg.

Stavudine Capsules, indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents, are the generic version of Bristol-Myers Squibb's Zerit(R) Capsules. This product had annual U.S. sales of approximately $54 million for the 12 months ending Sept. 30, 2008, for the noted strengths, according to IMS Health.

The product was shipped immediately under the Mylan Pharmaceutical Inc. label.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.