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13 November, 2019 09:53 IST
Aurobindo Pharma receives USFDA approval for anti-HIV drug
Source: IRIS | 21 Aug, 2017, 10.17AM
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Aurobindo Pharma has received tentative approval from the US Food & Drug Administration (USFDA) under the US 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 along 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. The triple combination product is expected to be launched in sub-Saharan Africa in Q3FY18.

Shares of the company gained Rs 4, or 0.57%, to trade at Rs 708.50. The total volume of shares traded was 92,531 at the BSE (10.07 a.m., Monday).

Aurobindo Pharma Limited   (Q,N,C,F)*

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