Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected diabetes mellitus 1 milestone | |||||
| 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® (insulin...” novonordisk.com ↗ “Complete Response Letter fra de amerikanske sundhedsmyndigheder, FDA, vedrørende registreringsansøgningerne for Tresiba® (insulin degludec) og Ryzodeg® (insulin...” novonordisk.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | US (FDA) | Ryzodeg | — | 2015-04-07 | “FDA has accepted for review the Class II Resubmissions for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart).” novonordisk.com ↗ “har accepteret de genindsendte registreringsansøgninger for Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart)” novonordisk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT00978627 | Aug 2009 → May 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
Press releases naming this drug 16 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 NCT00978627 ↗ |
| Known as | IDegAsp | “To evaluate efficacy and tolerability of a co-formulation of insulin degludec and insulin aspart (IDegAsp) with insulin aspart (IAsp) at other meals compared with basal-bolus...” PMID 22933438 ↗ Aug 2012 |
| Route | Subcutaneous | “Injected subcutaneously (under the skin) once daily with a meal.” NCT00978627 ↗ |