Skip to Content

Isentress Approval History

  • FDA approved: Yes (First approved October 12th, 2007)
  • Brand name: Isentress
  • Generic name: raltegravir
  • Dosage form: Tablets
  • Company: Merck & Co., Inc.
  • Treatment for: HIV Infection

Isentress (raltegravir) is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Development History and FDA Approval Process for Isentress

Nov 29, 2017Approval Merck Receives FDA Approval for Isentress (raltegravir), in Combination with Other Antiretroviral Agents, for the Treatment of HIV-1 Infection in Newborns Weighing at Least 2 kg
May 30, 2017Approval Merck Receives FDA Approval of Isentress HD (raltegravir), a New Once-Daily Option for the Combination Treatment of HIV-1 Infection in Appropriate Patients
Jul  2, 2013Approval FDA Approves New U.S. Labeling for Isentress (raltegravir) to Include 240-Week Results from STARTMRK Study of Isentress Containing Regimen in Previously Untreated HIV-1 Infected Adult Patient
Dec 21, 2011Approval FDA Expands Use of HIV Drug Isentress to Children and Adolescents
Feb  5, 2009Approval HIV/AIDS Update - Traditional Approval of Isentress (raltegravir)
Oct 12, 2007Approval FDA Approves of Isentress (raltegravir)
Oct 12, 2007Impending FDA Approval Decision on the First HIV Integrase Inhibitor Isentress Can Have Significant Impact for Patients
Sep  6, 2007FDA Advisory Committee Unanimously Recommends Accelerated Approval of Isentress (raltegravir), Merck's Investigational Oral Integrase Inhibitor, for Treatment of HIV
Jun 27, 2007FDA Priority Review Granted for Isentress (raltegravir), Merck's Investigational Integrase Inhibitor for HIV

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.