Aurobindo Pharma Limited is pleased to announce that the company has received tentative approval from the U.S. FDA under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (TLD) tablets, 50mg/300mg/300mg.
The approved product is used for the treatment of HIV-1 infection alone as a complete regimen in adults and pediatric patients weighing 40 kg and greater.
The reference listed drugs of the approved combination product are ViiV Healthcare’s Tivicay® (dolutegravir) and Epivir® (Lamivudine), and Gilead Science’s Viread® (Tenofovir Disoproxil Fumarate). 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.
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About Aurobindo Pharma Limited:
Aurobindo Pharma Limited (www.aurobindo.com) , headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. 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 AntiDiabetics, supported by an outstanding R&D set-up. The Company is marketing these products globally, in over 150 countries.
please contact: Krishna Kiran
Investor Relations
Phone: 040-66725401 / 66725000
Mobile: +91 98486 67906
Email: ir@aurobindo.com
