Aurobindo receives first NDA approval for HIV-1 drug from US FDA
16 Mar 2006
Aurobindo
Pharma Ltd has announced having received the first new
drug approval (NDA) from US FDA for Lamivudine 150mg
/ Zidovudine 300mg for fixed-dose'' tablets co-packed
with Efavirenz 600mg Tablets.
There is no previous version of this co-packaged product approved by US FDA. The company''s Lamivudine / zidovudine fixed dose combination tablet is a version of Combivir tablets manufactured by Glaxosmithkline, and the Efavirenz tablets are a version of Sustiva tablets manufactured by Bristol Myers-Squibb.
This tentative approval through US FDA''s expedited review process is under the PEPFAR. initiative. Apart from several ANDA approvals, Aurobindo Pharma could take advantage of the R&D skills by way of getting its first New Drug Approval.
This NDA provides Lamivudine 150mg / Zidovudine 300mg fixed-dose tablets co-packed with Efavirenz 600mg tablets for the treatment of HIV-1 infection.
This is Aurbindo Pharma''s 11th approval for the ARV segment and this will also help the company to retain as a strong player in anti retro viral segment.
Being a fully integratedmanufacturer Aurbindo Pharma is geared to penetrate into branded generic formulations for various regulated markets.