FDA — authorised 7 June 2000
- Marketing authorisation holder: NOVO NORDISK INC
- Status: approved
🇺🇸 Novolog in United States
FDA authorised Novolog on 7 June 2000
Marketing authorisations
FDA — authorised 28 November 2008
- Application: BLA021172
- Marketing authorisation holder: NOVO NORDISK INC
- Indication: Labeling
- Status: approved
FDA — authorised 14 January 2015
- Application: BLA020986
- Marketing authorisation holder: NOVO NORDISK INC
- Indication: Efficacy
- Status: approved
FDA — authorised 25 September 2015
- Application: BLA203313
- Marketing authorisation holder: NOVO
- Local brand name: RYZODEG 70/30
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 29 September 2017
- Application: BLA208751
- Marketing authorisation holder: NOVO
- Local brand name: FIASP FLEXTOUCH
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 14 February 2025
- Application: BLA761325
- Marketing authorisation holder: SANOFI-AVENTIS U.S. LLC
- Local brand name: MERILOG SOLOSTAR
- Indication: INJECTION — SOLUTION
- Status: approved
FDA — authorised 15 July 2025
- Application: BLA761188
- Marketing authorisation holder: BIOCON BIOLOGICS INC
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
BIOCON BIOLOGICS INC received marketing authorisation from the FDA for Novolog on 2025-07-15. This approval was granted under the standard expedited pathway for a new formulation or new manufacturer of the drug. Novolog is a medication used to treat diabetes.
Novolog 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 Novolog approved in United States?
Yes. FDA authorised it on 7 June 2000; FDA authorised it on 28 November 2008; FDA authorised it on 14 January 2015.
Who is the marketing authorisation holder for Novolog in United States?
NOVO NORDISK INC holds the US marketing authorisation.