FDA Approves Generic Version Of Antiretroviral Zerit
Mylan Inc. (Nasdaq: MYL) today 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 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.