Aurobindo Pharma receives USFDA tentative approval for Dolutegravir, allowing the product to be launched in the PEPFAR market
22 Sept 2016, Hyderabad, India - Aurobindo Pharma Limited is pleased to announce the tentative approval of Dolutegravir 50mg from US Food & Drug Administration (USFDA) for the treatment of HIV. This important milestone marks the first FDA approval of a generic version of Dolutegravir (DTG), an integrase strand transfer inhibitor recommended for use in treatment-naïve patients by the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Through an innovative collaboration with ViiV and the Clinton Health Access Initiative, Inc. (CHAI), the product is expected to be launched in sub-Saharan Africa in late 2016.
The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Tivicay®, of ViiV Healthcare.
ViiV Healthcare and Aurobindo Pharma signed a licensing agreement in 2014 that allows Aurobindo Pharma to supply Dolutegravir 50mg in 92 licensed countries, following completion of required local regulatory approval processes.
Commenting on the development, Mr. N. Govindarajan, Managing Director of Aurobindo Pharma Limited said:
“The approval of the generic version of DTG shows the commitment towards the larger cause of bringing affordable HIV drugs to millions of people. This is a one-of-its-kind agreement between innovator and generic company where the generic version of the drug will be launched in around three years from the originator product. Further, we are also developing a fixed dose combination of DTG.”
David Ripin, Executive Vice President of the Clinton Health Access Initiative, Inc. notes,
“Dolutegravir is a critical new tool that will help us achieve the UNAIDS 90-90-90 goals and an AIDS-free generation. The WHO included Dolutegravir in its recommendations for first-line therapy in 2015, and we expect rapid growth in demand now that a cost-effective generic product is available. Dolutegravir, taken with other HIV treatments, has the potential to improve the lives of millions of patients.”
Dolutegravir 50mg is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.
About Aurobindo Pharma
Aurobindo Pharma Limited ( www.aurobindo.com ) (NSE: AUROPHARMA, BSE: 524804, Reuters: ARBN.NS, Bloomberg: ARBP:IN), headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. A vertically integrated pharmaceutical company that delivers innovative solutions and 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. The company's manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The company's robust product portfolio is spread over 7 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, Anti-Allergies and Anti-Diabetics, supported by an outstanding R&D set-up. The Company is marketing these products globally, in over 150 countries.
About Clinton Health Access Initiative, Inc.
The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to strengthening integrated health systems and expanding access to care and treatment in the developing world. CHAI's solution-oriented approach focuses on improving market dynamics for medicines and diagnostics; lowering prices for treatment; accelerating access to lifesaving technologies; and helping governments build the capacity required for high-quality care and treatment programs. For more information, please visit: http://www.clintonhealthaccess.org
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