Aurobindo Pharma submits for tentative approval of new HIV medicine
LONDON – ViiV Healthcare, Aurobindo Pharma and the Clinton Health Access Initiative announced Tuesday that Aurobindo Pharma has submitted an abbreviated new drug application for dolutegravir 50 mg to the Food and Drug Administration for the treatment of HIV. This is the first ANDA for a generic version of dolutegravir, less than two years after FDA approval of ViiV Healthcare's Tivicay (dolutegravir) for sale in the United States.
"This first ANDA for a generic dolutegravir confirms that our strong commitment to thinking and acting differently to pursue new ways to expand access to our medicines, for people living with HIV in countries where the need is most pressing, is working," stated Dominique Limet, CEO, ViiV Healthcare.
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 program, 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 exclusivity that would have otherwise prevented FDA review and tentative approval of Aurobindo Pharma's ANDA at this time.
The filing by Aurobindo Pharma is the second result of the agreement between CHAI and ViiV Healthcare and comes less than six months after another generic manufacturer announced that it had received tentative approval from the FDA for pediatric formulations of another ViiV Healthcare antiretroviral (also under PEPFAR for sale in licensed countries outside of the United States), through innovative collaboration with ViiV Healthcare and CHAI.
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