Generics
Aurobindo Pharma gets tentative FDA approval for dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets
21 August 2017 -

India-based Aurobindo Pharma (NSE: AUROPHARMA) has been granted tentative approval by the US Food and Drug Administration (FDA) for dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets, the company said on Monday.

Aurobindo, a manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, said that the tablets are used for the treatment of HIV and will now be available in the US market.

The company received tentative approval under the US President's Emergency Plan for AIDS Relief (PEPFAR) for its new drug application for dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets, 50mg/300mg/300mg.

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 Pharma signed a licensing agreement with ViiV Healthcare in 2014 that allows the company to supply dolutegravir 50mg in 92 licensed countries, following completion of required local regulatory approval processes.

Aurobindo also stated that the triple combination product is expected to be launched in sub-Saharan Africa in the third quarter of fiscal year 2018.

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