USFDA gives nod to Strides Pharma Global’s HIV drug

Drug firm Strides Pharma Global has received approval from the US health regulator for Emtricitabine and Tenofovir Disoproxil Fumarate tablets, used to treat HIV, said its wholly-owned subsidiary, Strides Pharma Science on Friday.

In a regulatory filing, the pharma company said, Strides Pharma Global in Singapore, has received approval for Emtricitabine and Tenofovir Disoproxil Fumarate tablets in the strengths of 200 mg/300 mg from the United States Food and Drug Administration (USFDA). Quoting IQVIA moving annual total (MAT) November 2020 data, Strides Pharma Science said the US market for the tablets is approximately USD 2.4 billion.

The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma in the US market.

The company has 127 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 95 ANDAs have been approved and 32 are pending approval.

Shares of Strides Pharma Science were trading 0.83 per cent higher at Rs 929 apiece on BSE.

Subscribe to our newsletter
Subscribe to our newsletter
Sign up here to get the latest news delivered directly to your inbox.
You can unsubscribe at any time