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Mylan’s subsidiary wins FDA approval for generic Zerit capsules

US-based pharmaceutical company Mylan has announced that Matrix Laboratories, its India-based subsidiary in which it holds a 71.5% controlling interest, has received final approval from the FDA for its abbreviated new drug application for stavudine capsules USP, 15mg, 20mg, 30mg and 40mg.

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.

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