Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for review two New Drug Applications (NDAs) for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection in adults. The NDAs include data for doravirine (DOR) as a once-daily tablet for use in combination with other antiretroviral agents, and for use of doravirine with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) in a once-daily fixed-dose combination single tablet as a complete regimen (DOR/3TC/TDF). The FDA has set a target action date of Oct. 23, 2018, for both applications under the Prescription Drug User Fee Act (PDUFA).