On Nov. 23, 2020, Viatris announced tentative approval from the FDA for a New Drug Application for pediatric dolutegravir tablets for oral suspension, 10 mg. The new formulation is a result of a collaboration with ViiV Healthcare, the Clinton Health Access Initiative and Unitaid to help expand access to children living with HIV/AIDS in low- and middle-income countries.

Tentative approval was granted under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) which permits products that are not approved for marketing in the U.S. because of patent protection or other marketing restrictions to be distributed in other countries where they are critically needed.