Aurobindo Pharma Submits ANDA for FDA Approval on Generic Dolutegravir for the Treatment of HIV

ViiV Healthcare, Aurobindo Pharma (NSE:AUROPHARMA), and the Clinton Health Access Initiative Inc. announced that Aurobindo Pharma has submitted an Abbreviated New Drug Application (ANDA) for dolutegravir 50mg for the treatment of HIV.

As quoted in the press release:

This is the first ANDA for a generic version of dolutegravir, less than two years after FDA approval of Tivicay® (dolutegravir) for sale in the United States.

Upon receiving Tentative Approval from the FDA, Aurobindo Pharma will be able to supply dolutegravir 50mg via the President’s Emergency Plan for AIDS Relief (PEPFAR) programme, following completion of required local regulatory approval process, in the licensed countries outside of the United States, as per the agreement signed between Aurobindo Pharma and ViiV Healthcare in 2014.

This submission comes less than five years after ViiV Healthcare and CHAI signed an agreement to collaborate with the goal of bringing innovative formulations of medicines for the treatment and prevention of HIV/AIDS to people living with HIV in developing countries, on an affordable yet sustainable basis.

CHAI and ViiV Healthcare worked together to identify a generic partner after conducting feasibility research. Following this initial joint work, ViiV Healthcare submitted necessary documentation to the FDA providing a selective waiver letter for the five-year period of New Chemical Entity (NCE) exclusivity that would have otherwise prevented FDA review and Tentative Approval of Aurobindo Pharma’s ANDA at this time.

N. Govindarajan, managing director of Aurobindo Pharma, commented:

We are pleased to be part of this innovative partnership designed to accelerate access to medicines for treating HIV. Aurobindo Pharma is committed to HIV care and aims to achieve the goals of wider access to HIV treatment, care, and support; seeking to address the spread of HIV through development of this newer class of drugs and fixed-dose combinations for low- and middle-income countries.

Click here to read the full ViiV Healthcare, Aurobindo Pharma (NSE:AUROPHARMA), and the Clinton Health Access Initiative Inc. press release.