Aurobindo Pharma Ltd has received the first New Drug Approval (NDA) from US FDA for Lamivudine 150 mg/Zidovudine 300 mg Fixed - Dose Tablets co-packed with Efavirenz 600 mg Tablets.
This is another tentative approval through US FDA's expedited review process under PEPFAR initiative. Apart from several ANDA approvals, the company could take advantage of the R & D skills by way of getting its first New Drug Approval.
This NDA provides Lamivudine 150 mg/Zidovudine 300 mg Fixed-Dose Tablets co-packed with Efavirenz 600 mg Tablets for the treatment of HIV-1 infection. There is no previous version of this co-packaged product approved by US FDA.
According to the release, this is the company's eleventh approval for the ARV segment and this will also help the company to retain as a strong player in 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 by Bristol Myers-Squibb.