It said with the approval, several patients under PEPFAR would benefit.
Hyderabad, July 3
Aurobindo Pharma Ltd has announced that it has received the first tentative new drug application (NDA) approval from the United States Food and Drug Administration for fixed dose combination drug product containing lamivudine, zidovudine and nevirapine tablets (NDA) used in the treatment of HIV-1 infection.
In a press release here on Monday, APL said the three drugs were now available in a single tablet and it is the sole manufacturer of this approved combination.
This fixed dose combination pill comprising two-nucleoside reverse transcriptase inhibitors and a non-nucleoside reverse transcriptase inhibitors is used as first line therapy in most HIV patients. In most parts of the world, the regimen containing Lamivudine, Zidovudine and Nevirapine is very popular.
The company said with the approval , several patients under the US President's Emergency Programme for AIDS Relief would benefit.
According to Aurobindo Pharma, this is the first NDA generic approval in the world (innovator does not have this fixed dose combination) for a three-drug combination (amongst anti-retrovirals).
These drugs command $4.5-billion market worldwide and the usage is growing due to the commitment of the US Government in particular and the World Health Organisation to rehabilitate HIV patients. With this approval, the anti-retroviral product portfolio of the company has increased to 15 including two NDA approvals, the release said.