Strides Pharma Science Singapore arm secures USFDA tentative okay for HIV drug Dolutegravir
This medication is the first line of antiretroval therapy for treatment naïve patients.;
Bangalore: Strides Pharma Science Limited has announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received tentative approval for Dolutegravir 50mg tablets from the United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tivicay Tablets of ViiV Healthcare Company.
Dolutegravir tablets belong to a class of medication knows as antiretrovirals. This medication is the first line of antiretroval therapy (ART) for treatment naïve patients. It works by preventing the multiplication of the virus in human cells.
The approval adds to a list of products that Strides has approved under the PEPFAR pathway taking the total to 13 products. The Dolutegravir 50mg tablet has a market opportunity in the US of ~US$ 1,345Mn per IQVIA.
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