Drugs / Canagliflozin/metformin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | type 2 diabetes mellitus | 2013-12-12 | “FDA Issues Complete Response Letter for Canagliflozin/Metformin Fixed -Dose Combination Therapy for Type 2 Diabetes” jnj.com ↗ |
| Filed | EU (EMA) | — | type 2 diabetes mellitus | 2013-03-07 | “Janssen Submits European Marketing Authorisation Application for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes” jnj.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01508182 | Jan → Mar 2012 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2018-10-30 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves INVOKANA® (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease jnj.com ↗
This new indication also applies to the fixed-dose combinations of INVOKAMET® (canagliflozin/metformin HCl) tablets and INVOKAMET® XR (canagliflozin/metformin HCl extended-release) tablets. |
| 2014-08-08 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves INVOKAMET® (canagliflozin/metformin HCl) for the Treatment of Adults with Type 2 Diabetes jnj.com ↗
Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved INVOKAMET™ , a fixed-dose therapy combining canagliflozin and metformin hydrochloride in a single tablet, for the treatment of adults with type 2 diabetes. |
| 2013-12-12 | Janssen Research & Development, LLC | Regulatory FDA Issues Complete Response Letter for Canagliflozin/Metformin Fixed-Dose Combination Therapy for Type 2 Diabetes jnj.com ↗
The complete response letter related to the NDA requested additional information to support the comparability of the twice -daily dosing regimen of canagliflozin -- as part of the canagliflozin and metformin FDC -- and the once -daily dosing of canagliflozin as a single agent. |
| 2013-03-07 | Janssen Research & Development, LLC | Regulatory Janssen Submits European Marketing Authorisation Application for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes jnj.com ↗
Janssen Submits European Marketing Authorisation Application for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-10-30 | Janssen Research & Development, LLC | U.S. FDA Approves INVOKANA® (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease jnj.com ↗ |
| 2014-08-08 | Janssen Research & Development, LLC | U.S. FDA Approves INVOKAMET® (canagliflozin/metformin HCl) for the Treatment of Adults with Type 2 Diabetes jnj.com ↗ |
| 2013-12-12 | Janssen Research & Development, LLC | FDA Issues Complete Response Letter for Canagliflozin/Metformin Fixed-Dose Combination Therapy for Type 2 Diabetes jnj.com ↗ |
| 2013-03-07 | Janssen Research & Development, LLC | Janssen Submits European Marketing Authorisation Application for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes jnj.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Canagliflozin/metformin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01508182 ↗ |
| Route | Oral | “route = oral use” NCT01508182 ↗ |