Business Standard

Aurobindo gets USFDA nod for HIV-1 drug

US FDA has granted the approval for its Efavirenz+Lamivudine+ Tenofovir Disoproxil Fumarate Tablets

BS Reporter Hyderabad
Aurobindo Pharma Limited has received tentative approval to manufacture and market Efavirenz+Lamivudine+Tenofovir Disoproxil Fumarate  tablets, 600mg, 300mg, 300mg, from the US Food & Drug Administration (USFDA).

The new drug application (NDA)  provides for the treatment of HIV-1 infection in adults and adolescents aged more than 16 years of age and weighing at least 40 kg, the company stated in a press release on Friday.

This new drug application  was reviewed under the President’s Emergency Plan for AIDS Relief (PEPFAR). The estimated ARV (anti-retroviral) access market (emerging markets) for the product was $120 million last year and is expected to record strong growth in the coming year.

Aurobindo now has a total of 191 abbreviated NDA approvals (163 final approvals, including 4 from Aurolife Pharma LLC, and 28 tentative approvals) from the USFDA.
 

Don't miss the most important news and views of the day. Get them on our Telegram channel

First Published: Jun 28 2013 | 8:29 PM IST

Explore News