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.india Updated: Mar 16, 2006 12:33 IST
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.
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.