Drugs / Maxalt
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | RIZAFILM | — | 2026-02-26 | fda.gov ↗ |
| Label expansions (4) | US (FDA) | MAXALT | — | 1999-11-16 – 2011-12-16 | fda.gov ↗ |
| Approved | US (FDA) | MAXALT-MLT | — | 1998-06-29 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 41 trial | ||||||
| Phase 4 | NCT00719134 | Sep 2008 → Dec 2013 | migraine disorder | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT06473597 Comparator | Sep 2024 → Dec 2028 expected | migraine disorder | Antonios Likourezos | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2014-05-21 | RedHill Biopharma Limited | Results IntelGenx and RedHill Biopharma Report Positive Bioavailability Study Results in Support of Planned European Marketing Application in Q3/2014 for Anti-Migraine VersaFilm(TM) Product redhillbio.com ↗
The study, which included 26 healthy volunteers, established the bioequivalence of the anti-migraine VersaFilm™ product and the European reference drug, Maxalt® lingua. |
| 2014-02-04 | RedHill Biopharma Limited | Regulatory RedHill Biopharma and IntelGenx Receive Complete Response Letter from FDA for RHB-103 Oral Film for Acute Migraines redhillbio.com ↗
today announced that they received a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding the New Drug Application ("NDA") for RHB-103 for the treatment of acute migraines. |
| 2013-03-27 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Submits New Drug Application to U.S. FDA for RHB-103 Anti-Migraine Oral Thin Film redhillbio.com ↗ |
| 2008-04-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Generic Maxalt® Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2014-05-21 | RedHill Biopharma Limited | IntelGenx and RedHill Biopharma Report Positive Bioavailability Study Results in Support of Planned European Marketing Application in Q3/2014 for Anti-Migraine VersaFilm(TM) Product redhillbio.com ↗ |
| 2014-02-04 | RedHill Biopharma Limited | RedHill Biopharma and IntelGenx Receive Complete Response Letter from FDA for RHB-103 Oral Film for Acute Migraines redhillbio.com ↗ |
| 2013-03-27 | RedHill Biopharma Limited | RedHill Biopharma Submits New Drug Application to U.S. FDA for RHB-103 Anti-Migraine Oral Thin Film redhillbio.com ↗ |
| 2008-04-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval Of Generic Maxalt® Tablets tevapharm.com ↗ |
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 | Maxalt | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00719134 ↗ |
| Known as | Rizatriptan Benzoate | “Rizatriptan Benzoate (Maxalt MLT-ODT)” NCT06473597 ↗ |
| Action | Activate | “Rizatriptan benzoate (MAXALT), is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.” NCT06473597 ↗ |
| Route | Oral | “Rizatriptan ODT 10mg orally disintegrating tablets” NCT06473597 ↗ |