FDA — authorised 16 October 2006
- Application: NDA021995
- Marketing authorisation holder: MERCK SHARP DOHME
- Local brand name: JANUVIA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Januvia in United States
FDA authorised Januvia on 16 October 2006
Marketing authorisations
FDA — authorised 28 August 2015
- Application: NDA202270
- Marketing authorisation holder: MSD SUB MERCK
- Indication: Labeling
- Status: approved
FDA — authorised 26 October 2018
- Application: NDA209805
- Marketing authorisation holder: MSD SUB MERCK
- Indication: Labeling
- Status: approved
FDA — authorised 18 October 2023
- Application: NDA211566
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: ZITUVIO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 November 2023
- Application: NDA216743
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA
- Application: ANDA216086
- Marketing authorisation holder: MSN LABORATORIES PRIVATE LTD
- Local brand name: SITAGLIPTIN
- Indication: TABLET — FILM COATED
- Status: approved
FDA
- Application: ANDA217041
- Marketing authorisation holder: FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO.,
- Local brand name: SITAGLIPTIN
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA218441
- Marketing authorisation holder: BIOCON PHARMA LTD
- Local brand name: SITAGLIPTIN
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA216337
- Marketing authorisation holder: SCIEGEN PHARMACEUTICALS INC
- Local brand name: SITAGLIPTIN
- Indication: TABLET — FILM COATED
- Status: approved
FDA
- Application: ANDA216919
- Marketing authorisation holder: MANKIND PHARMA LTD
- Local brand name: SITAGLIPTIN
- Indication: TABLET — FILM COATED
- Status: approved
FDA
- Application: ANDA216057
- Marketing authorisation holder: LAURUS LABS LTD
- Local brand name: SITAGLIPTIN
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA215220
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
Januvia in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Januvia approved in United States?
Yes. FDA authorised it on 16 October 2006; FDA authorised it on 28 August 2015; FDA authorised it on 26 October 2018.
Who is the marketing authorisation holder for Januvia in United States?
MERCK SHARP DOHME holds the US marketing authorisation.