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Strides get USFDA approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets
United States Food & Drug Administration
Strides Pharma Science Limited's step-down wholly-owned subsidiary, Strides Pharma Global Pte.
Strides Pharma Science Limited's step-down wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received United States Food & Drug Administration (USFDA) approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg.
Strides Pharma in a regulatory filing, today, January 15, 2021, said, "Strides receives USFDA approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets."
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Truvada Tablets, 200 mg/300 mg, of Gilead Sciences.
According to IQVIA MAT, November 2020 data, the US market for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg is approximately US$ 2.4 Billion. The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
The company has 127 cumulative ANDA filings with USFDA of which 95 ANDAs have been approved and 32 are pending approval.
Emtricitabine and Tenofovir belong to the class of medications called nucleoside and nucleotide reverse transcriptase inhibitors. The combination of Emtricitabine and Tenofovir slows down the spread of HIV in the body and is used along with other medications to treat HIV in adults and children.
