Aurobindo gets USFDA nod for HIV drug

Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), Aurobindo Pharma Ltd, has received the tentative new drug application (NDA) approval for a fixed drug combination product used in the treatment of HIV-1 infection.

The product contains Lamivudine 150mg + Zidovudine 300mg tablets co-packaged with Abacavir 300mg tablets (NDA), a press release said.

The three drugs are now available in one single pack comprising two nucleoside reverse transcriptase inhibitors (NRTIs) and a non-nucleoside reverse transcriptase inhibitor (NNRTI), which inhibit replication of the virus.

In many parts of the world, the regimen containing Lamivudine, Zidovudine and Abacavir is popular. Such a therapy enhances compliance, is cost-effective and reduces the threat of resistance due to missed doses, the company said.

With the approval of such a combination by the US Food and Drug Administration (USFDA), patients under the President's Emergency Plan for AIDS Relief (PEPFAR) programme will be benefited.

This is the first NDA generic approval in the world for a three-drug combination pack. These three drugs have a global market of over $600 million in size.

Aurobindo buys US facility : https://www.business-standard.com/search/storypage_new.php?leftnm=1&leftindx=1&subLeft=1&autono=97634