Strides receives tentative US FDA approval for dolutegravir/ lamivudine/tenofovir disproxil fumurate tablets

Strides Pharma Science’s  step-down wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received tentative approval for its New Drug Application (NDA) 505b2 of dolutegravir/lamivudine/tenofovir disproxil fumurate 50mg/ 300mg/300mg tablets from the United States Food & Drug Administration (FDA). The product will be manufactured at the company’s facility in Bengaluru.
 
Approval of this product under the PEPFAR programme completes Strides’ qualification to all major markets and donor programmes including Global Fund and South Africa.
 
The PEPFAR tentative approval for Strides qualifies the company to participate in the PEPFAR programmes that procure this lifesaving medicine. Through country tenders and donor funded programs it is estimated that the value of procurement for dolutegravir/lamivudine/tenofovir disproxil fumurate 50mg/ 300mg/ 300mg tablets is ~USD 650 million.
 
The company has 260+ cumulative NDA/ANDA filings with US FDA, of which 230+ ANDAs have been approved. The company has set a target to launch ~60 new products over the next three years in the US.
 
Dolutegravir/lamivudine/tenofovir disproxil fumurate 50mg/ 300mg/300mg tablets is  a complete regimen for treatment of HIV-1 infection in adults and paediatric patients weighing at least 35kgs.

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