Drugs / insulin degludec/insulin aspart
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | Ryzodeg® | — | 2015-04-07 | “de amerikanske sundhedsmyndigheder (FDA) har accepteret de genindsendte registreringsansøgninger for Tresiba® (insulin degludec) og Ryzodeg®” novonordisk.com ↗ “FDA has accepted for review the Class II Resubmissions for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart).” novonordisk.com ↗ |
| Rejected (CRL) | US (FDA) | Ryzodeg® | — | 2013-02-08 | “it received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba® (insulin degludec) and Ryzodeg®” novonordisk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01713530 | Feb 2013 → Jan 2014 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2015-09-25 | Novo Nordisk A/S | Regulatory Novo Nordisk receives US FDA approval for Tresiba® and Ryzodeg® 70/30 novonordisk.com ↗
Bagsværd, Denmark, 25 September 2015 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Tresiba® and Ryzodeg® 70/30 for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Applications (NDAs). |
All press releases naming this drug 17 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | insulin degludec/insulin aspart | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01713530 ↗ |
| Known as | IDegAsp | “The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic...” NCT01713530 ↗ |
| Route | Subcutaneous | “For subcutaneous (s.c, under the skin) administration twice a day.” NCT01713530 ↗ |