Viatris: FDA Issues Tentative Approval For Single Tablet Regimen In HIV Treatment For Children

(RTTNews) - Viatris Inc. (VTRS) announced FDA tentative approval for a New Drug Application for abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension for the treatment of HIV-1 infection in paediatric patients. Abacavir/dolutegravir/lamivudine is a fixed-dose combination containing two nucleoside reverse transcriptase inhibitors and integrase strand transfer inhibitor.

The tentative approval through the President's Emergency Plan for AIDS Relief program means the formulation meets all the agency's quality, safety, and efficacy standards, the company noted.

Viatris has signed a licensing agreement for paediatric dolutegravir from the Medicines Patent Pool and development agreement with ViiV Healthcare and the Clinton Health Access Initiative for producing and distributing the fixed-dose combination.

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