ViiV Healthcare, Aurobindo Pharma, and the Clinton Health Access Initiative, Inc. (CHAI) announced that Aurobindo Pharma, has submitted to the Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for dolutegravir 50mg, for tentative approval, for HIV treatment. 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 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.
CHAI and ViiV Healthcare worked together. 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. 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 paediatric 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.
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (GSK) and Pfizer dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV.
The Clinton Health Access Initiative, Inc. (CHAI) was founded in 2002 with a transformational goal: help save the lives of millions of people living with HIV/AIDS in the developing world by dramatically scaling up antiretroviral treatment.
Aurobindo Pharma Ltd. manufactures generic pharmaceuticals and active pharmaceutical ingredients.Aurobindo Pharma leverages India's globally competitive cost base and talented team of scientists to discover, develop, and commercialize a range of affordable medicines for markets across the globe.
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