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Search results for darunavir in LACTMED (approximate match)
Showing 1 - 1 of 1 results
Status:
US Approved Rx
(2023)
Source:
ANDA215389
(2023)
Source URL:
First approved in 2006
Source:
NDA021976
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Darunavir (trade name Prezista) is an orally active bis-furan-sulfonamide inhibitor of human immunodeficiency virus (HIV-1) protease. Darunavir was developed by Tibotec Pharmaceuticals (now Janssen R&D Ireland). Darunavir is indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. The drug is co-administered with low-dose ritonavir and other anti-HIV agents. It is the only antiretroviral that has been registered at two different doses, 800/100 mg once-daily or 600/100 mg twice-daily, allowing its administration throughout the entire course of HIV disease, from naive subjects without any HIV-1 resistance to heavily treatment-experienced subjects with widespread triple-class family resistance.