Aurobindo gets approval from USFDA

Aurobindo Pharma has received the first NDA from USFDA for Lamivudine 150 mg, Zidovudine 300 mg fixed-dose tablets co-packed with Efavirenz 600 mg tablets.

Aurobindo Pharma Ltd said on Thursday that it has received the first New Drug Approval (NDA) from USFDA for Lamivudine 150 mg, Zidovudine 300 mg fixed-dose tablets co-packed with Efavirenz 600 mg tablets.

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This is another tentative approval through USFDA's expedited review process and this NDA provides drugs for treatment of HIV-1 infection, the pharma company informed the Bombay Stock Exchange.

The approval is the company's eleventh for the Anti Retro Viral segment.

The company's Lamivudine/zidovudine fixed dose combination tablet are a version of Combivir tablets manufactured by Glaxosmithkline, and the Efavirenz tablets are a version of Sustiva tablets manufactured b ristol Myers-Squibb, it said.