FDA — authorised 29 March 2013
- Application: NDA204042
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: INVOKANA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Invokana in United States
FDA authorised Invokana on 29 March 2013
Marketing authorisations
FDA — authorised 8 August 2014
- Application: NDA204353
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: INVOKAMET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 September 2016
- Application: NDA205879
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: INVOKAMET XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 April 2026
- Application: ANDA210449
- Marketing authorisation holder: APOTEX
- Local brand name: CANAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
The FDA approved APOTEX's Invokana (Canagliflozin) on 14 April 2026. This approval is for the treatment of type 2 diabetes. Invokana is a tablet taken orally, and it works by inhibiting the sodium-glucose cotransporter 2 (SGLT2) in the kidneys, reducing glucose reabsorption and increasing glucose excretion in the urine.
FDA — authorised 20 April 2026
- Application: ANDA210386
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CANAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Aurobindo Pharma Ltd's application (ANDA210386) for Invokana (Canagliflozin) on 20 April 2026. This approval allows Aurobindo Pharma Ltd to market Invokana in the United States for oral tablet use. Invokana is a medication used to treat type 2 diabetes and diabetic nephropathy.
FDA
- Application: ANDA210297
- Marketing authorisation holder: SANDOZ INC
- Local brand name: CANAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA210451
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: CANAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
Invokana 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 Invokana approved in United States?
Yes. FDA authorised it on 29 March 2013; FDA authorised it on 8 August 2014; FDA authorised it on 20 September 2016.
Who is the marketing authorisation holder for Invokana in United States?
JANSSEN PHARMS holds the US marketing authorisation.