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.
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
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.
NDA provides Lamivudine 150mg / Zidovudine 300mg fixed-dose
tablets co-packed with Efavirenz 600mg tablets for the
treatment of HIV-1 infection.
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.
a fully integratedmanufacturer Aurbindo Pharma is geared
to penetrate into branded generic formulations for various