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, 2017|| 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|| 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|| 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|| FDA Expands Use of HIV Drug Isentress to Children and Adolescents|
|Feb 5, 2009|| HIV/AIDS Update - Traditional Approval of Isentress (raltegravir)|
|Oct 12, 2007|| 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|
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