Sold as Fortovase. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Saquinavir (sold as Fortovase), first approved Nov 7, 1997, with 1 new use approved and 0 published complete response letters.
| Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)HIV-1-infection · Gilead Sciences | Phase 2 / Phase 3 | Active, not recruiting | Aug 16, 2022 |
| Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIVAcquired Immune Deficiency Syndrome (AIDS), HIV Infections · Gilead Sciences | Phase 2 / Phase 3 | Active, not recruiting | Dec 20, 2013 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Nov 7, 1997 | FortovaseNDA 20828 · New dosage form | Hoffmann La Roche | 13 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
