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® (insulin degludec/insulin aspart)” 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 | “modtaget et såkaldt Complete Response Letter fra de amerikanske sundhedsmyndigheder, FDA, vedrørende registreringsansøgningerne for Tresiba® (insulin degludec) og Ryzodeg®...” novonordisk.com ↗ “Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba® (insulin degludec) and Ryzodeg® (insulin...” novonordisk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01835431 | Oct 2013 → Nov 2014 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
Press releases naming this drug 16 releases
Evidence & citations 4 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 NCT01835431 ↗ |
| Known as | IDegAsp | “Insulin degludec/insulin aspart (IDegAsp) is a fixed soluble co-formulation of basal and bolus insulin.” PMID 30014589 ↗ Aug 2018 |
| Modality | Protein / enzyme biologic | “Insulin degludec/insulin aspart (IDegAsp) is a fixed soluble co-formulation of basal and bolus insulin.” PMID 30014589 ↗ Aug 2018 |
| Route | Subcutaneous | “Administered subcutaneously (s.c., under the skin) once daily with a main meal.” NCT01835431 ↗ |