Drugs / PN400
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | VIMOVO | arthritis, sacroiliac | 2009-06-30 | “has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for VIMOVO (PN400)” astrazeneca.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT00907400 | May → Sep 2009 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00761501 | Sep → Dec 2008 | — | AstraZeneca | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2010-10-11 | AstraZeneca | Regulatory Positive agreement received for approval of VIMOVO in Europe astrazeneca.com ↗
Monday, 11 October 2010 AstraZeneca and POZEN Inc. today announced that VIMOVO (naproxen/ esomeprazole magnesium) 500/20 mg modified-release tablets has cleared an important regulatory milestone by receiving positive agreement for approval in 23 countries across the European Union (EU). |
| 2010-04-30 | AstraZeneca | Regulatory FDA approved VIMOVO for arthritis patients at risk of developing NSAID-associated gastric ulcers astrazeneca.com ↗
AstraZeneca and POZEN Inc. today announced the US Food and Drug Administration (FDA) has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. |
| 2009-10-19 | AstraZeneca | Results Patients Taking VIMOVO(TM) Showed Decrease in incidence of NSAID Associated Ulcers astrazeneca.com ↗
Data from study PN400-301 showed a 4.1% incidence of GU in patients taking VIMOVO, compared to 23.1% among patients taking EC naproxen (p<0.001). |
| 2009-10-16 | AstraZeneca | Regulatory AstraZeneca Submits Marketing Authorisation Application to European Union for VIMOVO™ astrazeneca.com ↗ |
| 2009-08-31 | AstraZeneca | Regulatory AstraZeneca Announces FDA Acceptance of New Drug Application for VIMOVO astrazeneca.com ↗
the FDA’s notification of acceptance of the NDA filing for VIMOVO prompts a $10 million milestone payment from AstraZeneca to POZEN. |
| 2009-06-30 | AstraZeneca | Regulatory AstraZeneca Development Partner, Pozen, Inc., Submits New Drug Application for PN400 astrazeneca.com ↗
The NDA submission is based on data from a comprehensive clinical trials programme. |
| 2009-01-29 | AstraZeneca | Regulatory AstraZeneca’s Partner, POZEN Informed By FDA That Gastric Ulcers Are Valid Primary Endpoint In PN 400 Trials astrazeneca.com ↗ |
All press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2010-10-11 | AstraZeneca | Positive agreement received for approval of VIMOVO in Europe astrazeneca.com ↗ |
| 2010-04-30 | AstraZeneca | FDA approved VIMOVO for arthritis patients at risk of developing NSAID-associated gastric ulcers astrazeneca.com ↗ |
| 2009-10-19 | AstraZeneca | Patients Taking VIMOVO(TM) Showed Decrease in incidence of NSAID Associated Ulcers astrazeneca.com ↗ |
| 2009-10-16 | AstraZeneca | AstraZeneca Submits Marketing Authorisation Application to European Union for VIMOVO™ astrazeneca.com ↗ |
| 2009-08-31 | AstraZeneca | AstraZeneca Announces FDA Acceptance of New Drug Application for VIMOVO astrazeneca.com ↗ |
| 2009-06-30 | AstraZeneca | AstraZeneca Development Partner, Pozen, Inc., Submits New Drug Application for PN400 astrazeneca.com ↗ |
| 2009-01-29 | AstraZeneca | AstraZeneca’s Partner, POZEN Informed By FDA That Gastric Ulcers Are Valid Primary Endpoint In PN 400 Trials astrazeneca.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PN400 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00907400 ↗ |
| Route | Oral | “oral tablet” NCT00907400 ↗ |