Two New HIV Treatments Gain Approval From FDA – APhA submits compounding comments to FDA. – (866) 348-2889.
Officials with the FDA today approved Merck’s doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo) tablet and doravirine (Pifeltro) for the treatment of HIV-1, the company announced in a prepared statement.
Both drugs are indicated for oral, once-daily treatment in adult patients with HIV-1 infection who have had no prior antiretroviral treatment experience.
Delstrigo is a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg). Pifeltro, a new non-nuceloside reverse transcriptase inhibitor, is to be administered in combination with other antiretroviral medications.