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Aurobindo Pharma shares rallied as much as 1.6 percent in morning trade on tentative approval from USFDA for Dolutegravir, Lamivudine & Tenofovir Disoproxil Fumarate tablets.  “…. received tentative approval from the US Food and Drug Administration under the US President’s emergency plan for AIDs relief for new drug application for Dolutegravir, Lamivudine & Tenofovir Disoproxil Fumarate tablets,” the healthcare firm said in its filing.

This product is used for 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).

Aurobindo said the company and ViiV Healthcare signed a licensing agreement in 2014 that allows it 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.