Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | Ryzodeg | diabetes mellitus | 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 | diabetes mellitus | 2013-02-08 | “Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba® (insulin degludec) and Ryzodeg®” novonordisk.com ↗ “Complete Response Letter fra de amerikanske sundhedsmyndigheder, FDA, vedrørende registreringsansøgningerne for Tresiba® (insulin degludec) og Ryzodeg®” novonordisk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01814137 | Mar 2013 → Mar 2014 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2015-09-25 | Novo Nordisk A/S | Regulatory Novo Nordisk får FDA-godkendelse for Tresiba® og Ryzodeg® 70/30 i USA novonordisk.com ↗
I en separat handling meddeler Novo Nordisk desuden i dag, at virksomheden har indsendt registreringsansøgning til FDA for Xultophy®, det første kombinationsprodukt bestående af Tresiba® (insulin degludec) og Victoza® (liraglutid) til dosering én gang dagligt i én injektion. |
All press releases naming this drug 17 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | insulin degludec/insulin aspart | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01814137 ↗ |
| Known as | IDegAsp | “insulin degludec/insulin aspart (IDegAsp) showed good efficacy for achieving HbA1c <7%” PMID 27853981 ↗ Nov 2016 |
| Route | Subcutaneous | “For subcutaneous (s.c., under the skin) administration twice daily” NCT01814137 ↗ |