Aurobindo Pharma Ltd has received the first tentative NDA approval for fixed dose combination drug product containing Lamivudine + Zidovudine + Nevirapine Tablets (NDA) used in the treatment of HIV-1 infection. The three drugs are now available in one single tablet and the company is the sole manufacturer of this approved combination.

This fixed dose combination pill comprising two-nucleoside reverse transcriptase inhibitor (NRTIs) and a non-nucleoside reverse transcriptase inhibitor (NNRTIs) is used as a first line therapy in most HIV patients.

Aurbindo Pharma says the drug regimen containing Lamivudine, Zidovudine and Nevirapine is a commonly prescribed therapy in most parts of the world as this therapy is said to enhance the convenience, compliance and cost effectiveness. With the approval of such a combination by US FDA, the combination drug will also benefit patients under PEPFAR programme.

According to the company, this is the first NDA generic approval in the world — even the patent holder does not have this fixed dose combination — for a three-drug combination (amongst ARVS).

These three drugs command $4.5-billion dollar market worldwide and the usage of the drugs is growing due to the outstanding commitment of the US government and the WHO. With this approval, the ARV product portfolio of the Aurbindo Pharma has increased to 15 including two NDA approvals.