FDA — authorised 27 August 2012
- Marketing authorisation holder: GILEAD SCIENCES INC
- Status: approved
🇺🇸 Tybost in United States
FDA authorised Tybost on 27 August 2012
Marketing authorisations
FDA — authorised 28 August 2014
- Application: NDA203100
- Marketing authorisation holder: GILEAD SCIENCES INC
- Indication: Efficacy
- Status: approved
FDA — authorised 17 April 2015
- Application: NDA203094
- Marketing authorisation holder: GILEAD SCIENCES INC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 7 September 2018
- Application: NDA205395
- Marketing authorisation holder: JANSSEN PRODS
- Indication: Labeling
- Status: approved
FDA — authorised 18 March 2019
- Application: NDA207561
- Marketing authorisation holder: GILEAD SCIENCES INC
- Indication: Labeling
- Status: approved
FDA — authorised 7 February 2024
- Application: ANDA209986
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: COBICISTAT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 May 2025
- Application: NDA206353
- Marketing authorisation holder: BRISTOL
- Indication: Labeling
- Status: approved
The FDA approved Tybost, a drug developed by Bristol, on 12 May 2025. The approval was granted under the standard expedited pathway. The approved indication for Tybost is for its labelling.
FDA — authorised 27 February 2026
- Application: NDA220092
- Marketing authorisation holder: JANSSEN PRODS
- Local brand name: PREZCOBIX PED
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
The FDA approved Tybost (cobicistat), an HIV protease inhibitor booster, for use in combination with other antiretroviral agents. The approval was granted to Janssen Products under NDA220092 on 27 February 2026. The product is available in oral suspension and tablet formulations, marketed under the brand name Prezcobix Ped.
Tybost in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Tybost approved in United States?
Yes. FDA authorised it on 27 August 2012; FDA authorised it on 28 August 2014; FDA authorised it on 17 April 2015.
Who is the marketing authorisation holder for Tybost in United States?
GILEAD SCIENCES INC holds the US marketing authorisation.