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DESCOVY (nda208215)- (120MG;EQ 15MG BASE,200MG;EQ 25MG BASE)

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC
120MG;EQ 15MG BASE,200MG;EQ 25MG BASE
Yes No
2033-Feb-15 2020-Nov-05
None None
None No
HIV- 1 Treatment: DESCOVY is a two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated: • in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg. • in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor for the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg and less than 35 kg. HIV-1 PrEP: DESCOVY is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. Individuals must have a negative HIV-1 test immediately prior to initiating DESCOVY for HIV-1 PrEP.
2 3 0
Total Other Developers 21
Drugs with Suitability No
120MG;EQ 15MG BASE ** ** - - -
200MG;EQ 25MG BASE ** ** Up - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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