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BIKTARVY (nda210251)- (EQ 50MG BASE;200MG;EQ 25MG BASE,EQ 30MG BASE;120MG;EQ 15MG BASE)

BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC
EQ 50MG BASE;200MG;EQ 25MG BASE,EQ 30MG BASE;120MG;EQ 15MG BASE
Yes No
2036-Nov-08 2023-Feb-07
None None
None No
BIKTARVY is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of BIKTARVY.
0 1 0
Total Other Developers 12
Drugs with Suitability No
EQ 50MG BASE;200MG;EQ 25MG BASE ** ** Up - -
EQ 30MG BASE;120MG;EQ 15MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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