ALMOTRIPTAN MALATE · AJANTA PHARMA LTD
Almotriptan malate is a triptan indicated for the acute treatment of migraine attacks (with or without aura) in adults. In adolescents aged 12 to 17, it is indicated specifically for the acute treatment of migraine headache pain in patients whose untreated attacks typically last four hours or longer. Notably, efficacy for migraine-associated symptoms (nausea, photophobia, and phonophobia) has not been established in the adolescent population. The drug should only be used after a clear diagnosis of migraine is established and is not indicated for prophylactic therapy, cluster headaches, or the management of hemiplegic or basilar migraines.
How ALMOTRIPTAN MALATE Works
Almotriptan functions as a selective 5-HT 1B/1D receptor agonist. It binds with high affinity to 5-HT 1D, 5-HT 1B, and 5-HT 1F receptors, and demonstrates weak affinity for 5-HT 1A and 5-HT 7 receptors. This pharmacological activity at specific serotonin receptors mediates its therapeutic effect during acute migraine attacks. The drug shows no significant affinity or pharmacological activity at other sites, including alpha/beta-adrenergic, adenosine, angiotensin, dopamine, endothelin, or tachykinin receptors.
Details
- Status
- Prescription
- First Approved
- 2001-05-07
- Routes
- ORAL
- Dosage Forms
- TABLET
ALMOTRIPTAN MALATE Approval History
What ALMOTRIPTAN MALATE Treats
1 indicationsALMOTRIPTAN MALATE is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
ALMOTRIPTAN MALATE Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ALMOTRIPTAN MALATE FDA Label Details
Indications & Usage
Almotriptan tablets are a 5HT 1B/1D receptor agonist (triptan) indicated for: • Acute treatment of migraine attacks in adults with a history of migraine with or without aura • Acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more Important Limitations: • Use only after a clear diagnosis of migraine has been established • In adolescents age 12 to 17 years, efficacy of almotriptan tablets on migraine-associated symptoms was not established • Not intended for the pr...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.