Strides Pharma gets tentative USFDA approval for HIV drug dolutegravir
Dolutegravir, an antiretrovirals, is used to prevent multiplication of viruses in human cells. It is used to control the HIV infection, and limits the chances of new infections associated with the disease.
The Bengaluru-headquartered Strides Pharma's Singapore-based step down subsidiary, Strides Pharma Global Pte Ltd, has received tentative approval from the United Nations Food and Drug Administration (USFDA) for dolutegravir 50 mg tablet. Dolutegravir is an antiretrovirals and is used to prevent multiplication of viruses in human cells. It is used to control the HIV infection, and limits the chances of new infections associated with the deadly disease.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tivicay tablets of ViiV Healthcare Company.
PEPFAR’s (President's Emergency Plan for AIDS Relief) tentative approval for Strides qualifies the company to participate in global donor-funded programmes that procure this lifesaving medicine which is supplied in 126 countries, the drug firm said. As of 2022, donor procurement for dolutegravir 50mg tablets was estimated at a value of $35 million.
Strides Pharma now has a total to 13 products approved under the PEPFAR pathway. The company has 260 cumulative Abbreviated New Drug Application (ANDA) filings with the USFDA, out of which more than 230 have been approved. The company has set a target to launch 60 new products over three years in the US.
The dolutegravir 50mg tablet has a market opportunity of nearly $1,345 million in the US. The products will be manufactured at the company’s facility in Bengaluru, the pharma company said in an exchange filing.
(Edited by : Shoma Bhattacharjee)
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