Matrix Laboratories, a Indian subsidiary of Mylan Inc., with controlling stake of 71.5 per cent, has received final approval from the US FDA 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 US sales of approximately $54 million for the 12 months ended Sept. 30, 2008, for the noted strengths, according to IMS Health.
The product was shipped immediately under the Mylan Pharmaceutical Inc label.