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# Merck Files 2 NDAs on New HIV Drug
- URL: https://www.fdaweb.com/merck-files-2-ndas-on-new-hiv-drug/
- Published: 2018-01-08T12:00:00.000Z
- Updated: 2026-09-14T23:11:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140442

FDA has accepted for review two Merck NDAs for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor for treating HIV-1 infection in adults. The NDAs include data for doravirine 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 in a once-daily fixed-dose combination single tablet. The NDAs are based on data at week 48 of two ongoing Phase 3 trials, DRIVE-FORWARD and DRIVE-AHEAD, evaluating doravirine and the fixed-dose combination regimen, respectively. The agency has set a user fee target review action date of 10/23 for both applications.