New Delhi: Aurobindo Pharma Ltd has received tentative approval from the US Food and Drug Administration (US FDA) to manufacture and market Dolutegravir, used for treatment of HIV, in the US market.
In a BSE filing, Aurobindo Pharma said it has received “tentative approval for Dolutegravir 50mg from US Food & Drug Administration (USFDA) for the treatment of HIV.”
“Through an innovative collaboration with ViiV and the Clinton Health Access Initiative, Inc. (CHAI), the product is expected to be launched in sub-Saharan Africa in late 2016,” the filing said.
The approved abbreviated new drug application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product Tivicay, of ViiV Healthcare, 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.
Dolutegravir 50mg is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. “This important milestone marks the first FDA approval of a generic version of Dolutegravir (DTG), an integrase strand transfer inhibitor recommended for use in treatment-naïve patients by the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO),” the company said.
Aurobindo Pharma’s scrip surged over 6% on Thursday on getting the tentative approval. Shares of the company advanced by 6.33% to settle at Rs857.15 on BSE.
During the day, it jumped 6.67% to Rs860. At NSE, shares of the company rose 6.1% to end at Rs856.95. The company added Rs2,984.81 crore to Rs50,157.81 crore in market valuation.
On the volume front, 7.79 lakh shares of the company changed hands on BSE and over 76 lakh shares were traded on NSE during the day.