Aurobindo receives nod for Dolutegravir, Lamivudine & Tenofovir Disoproxil Fumarate tablets

21 Aug 2017 Evaluate

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.



Aurobindo Pharma Share Price

1136.30 11.55 (1.03%)
08-May-2024 16:01 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1520.00
Dr. Reddys Lab 6050.00
Cipla 1383.40
Zydus Lifesciences 1006.10
Lupin 1616.90
View more..
© 2024 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt.Ltd.