Hyderabad, March 16
Aurobindo Pharma Ltd has announced that it has received the first approval for its New Drug Application (NDA) from the US Food and Drug Administration (US FDA) for Lamivudine 150 mg/ Zidovudine 300 mg fixed-dose tablets co-packed with Efavirenz 600 mg tablets.
In a press release here on Thursday, the company said this is another tentative approval through US FDA's expedited review process under President Bush's Emergency Plan for AIDS Relief (PEPFAR) initiative. Apart from several ANDA (abbreviated new drug application) approvals, the company could take advantage of the R&D skills by way of getting its first NDA.
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, the company said.
This is the company's eleventh approval in the ARV (anti-retroviral) segment and the company expects the fresh NDA to help it retain its position as a strong player in the ARV segment. Being a fully integrated player, the company said it is geared up to penetrate into branded generic formulations for various regulated markets.
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, the release said.