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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

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

Further information

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