Drugs / levodopa/carbidopa/entacapone
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed juvenile-onset Parkinson disease 2 milestones | |||||
| Filed | US (FDA) | Stalevo | juvenile-onset Parkinson disease | 2012-03-26 | “Orion comments on ANDA filed by Mylan Pharmaceuticals Inc. for a generic version of Orion's proprietary drug Stalevo® (carbidopa/levodopa/entacapone) in the United States” orionpharma.com ↗ “26 Mar 2012 Orion comments on ANDA filed by Mylan Pharmaceuticals Inc. for a generic version of Orion's proprietary drug Stalevo® in the United States” orionpharma.com ↗ “ANDA filed by Mylan Pharmaceuticals Inc. for a generic version of Orion's proprietary drug Stalevo® in the United States” orionpharma.com ↗ “Mylan's submission of an abbreviated new drug application ("ANDA") for generic versions of Orion's Stalevo®” orionpharma.com ↗ “Orion has applied for an expanded indication for Stalevo® in the USA and Europe.” orionpharma.com ↗ |
| Filed | EU (EMA) | Stalevo | juvenile-onset Parkinson disease | — | “A European marketing application for the product is currently under review by the EMEA (European Medicinal Evaluation Agency).” orionpharma.com ↗ “Orion has applied for an expanded indication for Stalevo® in the USA and Europe.” orionpharma.com ↗ |
| Filed Parkinson disease 1 milestone | |||||
| Filed | Japan (PMDA) | Stalevo | Parkinson disease | — | “Novartis has submitted an application for marketing authorisation for Stalevo in Japan.” orionpharma.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT00125567 | Aug 2005 → Mar 2009 | Parkinson disease | Orion Corporation, Orion Pharma | Completed | Met primary |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2012-03-26 | Orion Corporation, Orion Pharma | Regulatory Orion comments on ANDA filed by Mylan Pharmaceuticals Inc. for a generic version of Orion's proprietary drug Stalevo® in the United States orionpharma.com ↗ |
| 2009-10-21 | Orion Corporation, Orion Pharma | Regulatory Orion withdraws US application for extending the indication of Stalevo® orionpharma.com ↗
Orion Corporation has withdrawn the US application for extending the current US indication of its proprietary drug Stalevo® (levodopa, carbidopa and entacapone) to patients with early Parkinson's disease. |
| 2009-03-06 | Orion Corporation, Orion Pharma | Regulatory Orion withdraws EU application for extending the indication of Stalevo® orionpharma.com ↗
Orion has decided to withdraw its EU application for extending the indication. |
| 2009-02-24 | Orion Corporation, Orion Pharma | Results Orion: Primary objective of STRIDE-PD study was not achieved orionpharma.com ↗
The result of the primary endpoint measured in STRIDE-PD, a clinical study with Orion's proprietary drug Stalevo® (levodopa, carbidopa and entacapone) in 747 patients with early Parkinson's disease (PD) requiring levodopa treatment, demonstrates that Stalevo does not delay the onset of involuntary movements, dyskinesia. |
| 2008-12-11 | Orion Corporation, Orion Pharma | Regulatory Orion comments on ANDA filed by Wockhardt Limited for a generic version of Orion's proprietary drug Stalevo® (25/200/100; 37.5/200/150 and 50/200/200 mg strengths) in the United States orionpharma.com ↗
Wockhardt's ANDA for Stalevo contains so-called Paragraph IV certifications challenging Orion U.S. patents Nos. 5,135,950; 5,446,194; 6,500,867; and 6,797,732 covering Stalevo and listed in the Orange Book, the FDA's official listing of approved drug products. |
| 2008-11-03 | Orion Corporation, Orion Pharma | Regulatory Orion comments on ANDA filed by Wockhardt Limited for a generic version of Orion's proprietary drug Stalevo® in the United States orionpharma.com ↗ |
| 2008-04-15 | Orion Corporation, Orion Pharma | Regulatory Orion seeking broader indication for Stalevo orionpharma.com ↗
The aim is to extend the indication of Stalevo to those early-stage patients whose Parkinson's Disease impairment requires the initiation of levodopa medication. |
| 2008-01-24 | Orion Corporation, Orion Pharma | Results Positive primary endpoint from FIRST-STEP study with Stalevo in early Parkinson's Disease orionpharma.com ↗
The treatment difference was statistically significant (p<0.05) in favour of Stalevo. |
| 2008-01-02 | Orion Corporation, Orion Pharma | Regulatory Orion comments on new challenge by Sun Pharmaceutical Industries Ltd., India, of Orion's U.S. Patent No. 5,446,194 covering its proprietary drug Stalevo® in the United States orionpharma.com ↗ |
| 2007-10-01 | Orion Corporation, Orion Pharma | Regulatory Orion comments on ANDA filing of generic versions of Orion's proprietary drug Stalevo® in the United States orionpharma.com ↗ |
| 2003-10-23 | Orion Corporation, Orion Pharma | Regulatory EU approval granted for Stalevo®, Orion's new treatment for Parkinson's disease orionpharma.com ↗ |
| 2003-09-01 | Orion Corporation, Orion Pharma | Results First results of three multicenter open-label clinical trials with StalevoTM show improved symptomatic benefits and enhanced convenience for patients with Parkinson's disease. orionpharma.com ↗ |
| 2003-06-13 | Orion Corporation, Orion Pharma | Regulatory Stalevo, Orion's new treatment for Parkinson's disease approved by the FDA orionpharma.com ↗
Orion Pharma has received an approval from the US FDA (Food and Drug Administration) for Stalevo, which combines levodopa and carbidopa with entacapone in one tablet for the treatment of Parkinson's disease (PD). |
| 2002-08-26 | Orion Corporation, Orion Pharma | Regulatory A new combined treatment for Parkinson's disease filed by Orion Pharma with the U.S. FDA orionpharma.com ↗
Three different strength combinations of the three active substances, levodopa, entacapone and carbidopa, are being registered. |
All press releases naming this drug 27 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 | levodopa/carbidopa/entacapone | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00125567 ↗ |
| Known as | Stalevo | “Stalevo (levodopa/carbidopa/entacapone)” NCT00125567 ↗ |
| Route | Oral | “Oral, 50-150 mg levodopa four times daily, for up to 2 years” NCT00125567 ↗ |