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Pifeltro FDA Approval History

FDA Approved: Yes (First approved August 30, 2018)
Brand name: Pifeltro
Generic name: doravirine
Dosage form: Tablets
Company: Merck
Treatment for: HIV Infection

Pifeltro (doravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of HIV-1 infection.

Pifeltro is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients:

  • with no prior antiretroviral treatment history, OR
  • to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.

Development Timeline for Pifeltro

DateArticle
Sep 20, 2019ApprovalMerck’s Pifeltro (doravirine) and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive FDA Approval for Use in Appropriate Adults Living with HIV-1 Who Are Virologically Suppressed
Aug 30, 2018ApprovalFDA Approves Merck’s Pifeltro (doravirine) for the Treatment of HIV-1 in Appropriate Patients
Jul 24, 2018Merck Announces Week 96 Data from Pivotal Phase 3 DRIVE-FORWARD Study of Its Investigational HIV Therapy Doravirine
Jan  8, 2018FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection

See Also

Pifeltro (doravirine) Consumer Information

Further information

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