Drugs / insulin degludec/insulin aspart
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01125553 | May → Aug 2010 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| 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 ↗
Bagsværd, den 25. september 2015 - Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder (FDA) efter at have afsluttet behandlingen af de genindsendte registreringsansøgninger har godkendt Tresiba® og Ryzodeg® 70/30 til behandling af diabetes hos voksne. |
| 2015-09-25 | Novo Nordisk A/S | Regulatory Novo Nordisk receives US FDA approval for Tresiba® and Ryzodeg® 70/30 novonordisk.com ↗
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). |
| 2015-04-07 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: Amerikanske FDA accepterer at behandle genindsendelserne af Tresiba® og Ryzodeg® novonordisk.com ↗
Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder (FDA) har accepteret de genindsendte registreringsansøgninger for Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) til behandling som en 'Class II Resubmission'. |
| 2015-04-07 | Novo Nordisk A/S | Regulatory US FDA accepts Tresiba® and Ryzodeg® resubmissions for review novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has accepted for review the Class II Resubmissions for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart). |
| 2013-02-10 | Novo Nordisk A/S | Regulatory Novo Nordisk receives Complete Response Letter in the US for Tresiba® and Ryzodeg® novonordisk.com ↗
Novo Nordisk today announced that on 8 February 2013 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® (insulin degludec/insulin aspart). |
| 2013-02-10 | Novo Nordisk A/S | Regulatory Novo Nordisk modtager Complete Response Letter i USA vedrørende Tresiba® og Ryzodeg® novonordisk.com ↗
Novo Nordisk meddeler i dag, at virksomheden den 8. februar 2013 har modtaget et såkaldt Complete Response Letter fra de amerikanske sundhedsmyndigheder, FDA, vedrørende registreringsansøgningerne for Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart). |
| 2013-01-21 | Novo Nordisk A/S | Regulatory Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) får markedsføringstilladelse i Europa novonordisk.com ↗
Bagsværd, den 21. januar 2013 - Novo Nordisk meddelte i dag, at Europa-Kommissionen har givet markedsføringstilladelse til Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) til behandling af diabetes hos voksne. |
| 2013-01-21 | Novo Nordisk A/S | Regulatory Tresiba® and Ryzodeg® receive marketing authorisations in Europe novonordisk.com ↗
Novo Nordisk today announced that the European Commission has granted marketing authorisations for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart) for the treatment of diabetes in adults. |
| 2012-12-25 | Novo Nordisk A/S | Regulatory Ryzodeg® (insulin degludec/insulin aspart) approved in Japan novonordisk.com ↗
Novo Nordisk today announced that the Japanese Ministry of Health, Labour and Welfare has approved Ryzodeg® (insulin degludec/insulin aspart) for the treatment of diabetes. |
| 2012-12-25 | Novo Nordisk A/S | Regulatory Ryzodeg® (insulin degludec/insulin aspart) godkendt i Japan novonordisk.com ↗
Bagsværd, den 25. december 2012 - Novo Nordisk meddelte i dag, at det japanske ministerium for sundhed, arbejde og velfærd har godkendt Ryzodeg® (insulin degludec/insulin aspart) til behandling af diabetes. |
| 2012-12-03 | Novo Nordisk A/S | Regulatory Ryzodeg® (insulin degludec/insulin aspart) passed review by First Committee on Drugs of Pharmaceutical Affairs in Japan novonordisk.com ↗
Novo Nordisk today announced that Ryzodeg® (insulin degludec/insulin aspart) has passed the review by the First Committee on Drugs of Japan's Pharmaceutical Affairs. |
| 2012-12-03 | Novo Nordisk A/S | Regulatory Ryzodeg® (insulin degludec/insulin aspart) passerer evaluering i japansk medicinkomite novonordisk.com ↗
Novo Nordisk meddelte i dag, at Ryzodeg® (insulin degludec/insulin aspart) har passeret evalueringen i en medicinsk komite under de japanske sundhedsmyndigheder, First Committee on Drugs of Japan's Pharmaceutical Affairs. |
| 2012-11-08 | Novo Nordisk A/S | Regulatory Positiv afstemning i FDA's rådgivende komite vedrørende godkendelse af insulin degludec og insulin degludec/ insulin aspart novonordisk.com ↗
Bagsværd, den 9. november 2012 Novo Nordisk meddelte i dag, at Endocrinologic and Metabolic Drugs Advisory Committee, som er en rådgivende komite for de amerikanske sundhedsmyndigheder (FDA), har afsluttet sit møde vedrørende registreringsansøgningerne for insulin degludec og insulin degludec/insulin aspart. |
| 2012-11-08 | Novo Nordisk A/S | Regulatory Insulin degludec and insulin degludec/insulin aspart receive positive vote for approval from FDA Advisory Committee novonordisk.com ↗ |
| 2012-10-25 | Novo Nordisk A/S | Regulatory FDA discloses focus of Advisory Committee meeting on insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has published information pertaining to the focus of the Advisory Committee meeting scheduled for 8 November 2012 to discuss the New Drug Applications for insulin degludec and insulin degludec/insulin aspart. |
| 2012-07-18 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: FDA berammer møde i rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗
Novo Nordisk meddelte i dag, at de amerikanske sundhedsmyndigheder, FDA, har oplyst, at man vil afholde et møde i FDA's rådgivende komite, hvor registreringsansøgningerne for ultralangtidsvirkende insulin degludec og insulin degludec/insulin aspart vil blive drøftet. |
| 2012-07-18 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: FDA schedules Advisory Committee meeting for insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗
an FDA Advisory Committee meeting is tentatively scheduled to be held on 8 November 2012 to discuss the New Drug Applications (NDA) for the ultra-long-acting insulin degludec and insulin degludec/insulin aspart. |
| 2012-06-08 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: FDA forlænger registreringssprocessen for insulin degludec og insulin degludec/insulin aspart med tre måneder novonordisk.com ↗
Novo Nordisk har i dag meddelt, at de amerikanske sundhedsmyndigheder (FDA) har forlænget registreringssprocessen for den ultralangtidsvirkende insulin degludec og insulin degludec/insulin aspart til behandling af type 1- og type 2-diabetes. |
| 2012-06-08 | Novo Nordisk A/S | Regulatory Novo Nordisk A/S: FDA extends regulatory review period for insulin degludec and insulin degludec/insulin aspart by three months novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has extended the regulatory review period for the ultra-long-acting insulins degludec and insulin degludec/insulin aspart for the treatment of type 1 and type 2 diabetes. |
All press releases naming this drug 24 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 NCT01125553 ↗ |
| Known as | NN5401 | “The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in healthy subjects.” NCT01125553 ↗ |
| Route | Subcutaneous | “The trial products will be administered as a subcutaneous injection (under the skin).” NCT01125553 ↗ |