Aurobindo Pharma gets USFDA nod for anti-HIV drug

Updated: Mon, Aug 21, 2017
12:40 pm
PTI
RELATED NEWS
U.S. will seek extradition of Huawei CFO from Canada U.S. will seek extradition of Huawei CFO from Canada
PAK, UAE sign USD 3 billion bailout package PAK, UAE sign USD 3 billion bailout package
Facing losses in Brazil, GM turns to Sao Paulo state for tax breaks Facing losses in Brazil, GM turns to Sao Paulo state for tax breaks
Oil drops nearly three percent on rising supplies, China slowdown Oil drops nearly three percent on rising supplies, China slowdown
Global Markets: Equities retreat as growth worries dent risk appetite Global Markets: Equities retreat as growth worries dent risk appetite

Aurobindo Pharma has received tentative approval from the USFDA for dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets, used for the treatment of HIV, in the US market.

In a BSE filing, Aurobindo Pharma said it has received "tentative approval from the US Food and 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 tablets.

The approval has been granted in strength of 50mg/ 300mg/ 300mg.

Aurobindo Pharma said the triple combination product is expected to be launched in sub-Saharan Africa in the third quarter of this fiscal.

The reference listed drugs of the approved combination products are ViiV Healthcare's Tivicay and Epivir and Gilead Science's Viread, it added.

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.

Shares of Aurobindo Pharma were trading 0.46 per cent higher at Rs 707.75 apiece on BSE.

 

(This article has not been edited by Zeebiz editorial team and is auto-generated from an agency feed.)