Final FDA OK for Mylan's generic Zerit
Matrix Laboratories, an India-based firm in which US drugmaker Mylan, holds a 71.5% controlling interest, received final approval from the US Food and Drug Administration on December 29, for its Abbreviated New Drug Application for stavudine capsules USP, 15mg, 20mg, 30mg and 40mg.
Stavudine, indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents, is the generic version of drug major Bristol-Myers Squibb's Zerit. This product had annual US sales of around $54.0 million for the 12 months ending September 30 for the noted strengths, according to IMS Health. The product was shipped immediately under the Mylan Pharmaceutical label.
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