FDA — authorised 22 January 1973
- Status: approved
🇺🇸 Proglycem in United States
FDA authorised Proglycem on 22 January 1973
Marketing authorisations
FDA — authorised 28 May 1976
- Application: NDA017453
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: PROGLYCEM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 20 December 2019
- Application: ANDA211050
- Marketing authorisation holder: E5 PHARMA INC
- Local brand name: DIAZOXIDE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 8 July 2020
- Application: ANDA210799
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: DIAZOXIDE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 26 March 2025
- Application: NDA216665
- Marketing authorisation holder: SOLENO THERAP
- Indication: Type 2 - New Active Ingredient
- Status: approved
The FDA approved Proglycem, a new active ingredient for Type 2 diabetes, on 26 March 2025. The marketing authorisation was granted to Soleno Therapeutics, the marketing authorisation holder. This approval was obtained through a standard expedited pathway.
FDA
- Application: ANDA071519
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: DIAZOXIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071908
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: DIAZOXIDE
- Indication: Injectable — Injection
- Status: approved
Proglycem 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 Proglycem approved in United States?
Yes. FDA authorised it on 22 January 1973; FDA authorised it on 28 May 1976; FDA authorised it on 20 December 2019.
Who is the marketing authorisation holder for Proglycem in United States?
Marketing authorisation holder not available in our data.