Isentress FDA Approval History
FDA Approved: Yes (First approved October 12, 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 timeline for Isentress
| Date | Article |
|---|
| Nov 29, 2017 | Approval 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, 2017 | Approval 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, 2013 | Approval 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, 2011 | Approval FDA Expands Use of HIV Drug Isentress to Children and Adolescents |
| Feb 5, 2009 | Approval HIV/AIDS Update - Traditional Approval of Isentress (raltegravir) |
| Oct 12, 2007 | Approval FDA Approves of Isentress (raltegravir) |
| Oct 12, 2007 | Impending FDA Approval Decision on the First HIV Integrase
Inhibitor Isentress Can Have Significant Impact for Patients |
| Sep 6, 2007 | FDA Advisory Committee Unanimously Recommends Accelerated Approval
of Isentress (raltegravir), Merck's Investigational Oral Integrase
Inhibitor, for Treatment of HIV |
| Jun 27, 2007 | FDA Priority Review Granted for Isentress (raltegravir), Merck's
Investigational Integrase Inhibitor for HIV |
Further information
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