FDA — authorised 7 July 2015
- Application: ANDA078027
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ALMOTRIPTAN MALATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 ALMOTRIPTAN MALATE in United States
FDA authorised ALMOTRIPTAN MALATE on 7 July 2015 · 2,002 US adverse-event reports
Marketing authorisations
FDA — authorised 9 November 2015
- Application: ANDA205171
- Marketing authorisation holder: MYLAN
- Local brand name: ALMOTRIPTAN MALATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 March 2016
- Application: ANDA205523
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: ALMOTRIPTAN MALATE
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 28 March 2025 – 28 March 2026
- Total reports: 2,002
Most-reported reactions
- Hyperhidrosis — 275 reports (13.74%)
- Nausea — 263 reports (13.14%)
- Drug Ineffective — 262 reports (13.09%)
- Nightmare — 260 reports (12.99%)
- Sedation — 260 reports (12.99%)
- Nephrolithiasis — 233 reports (11.64%)
- Off Label Use — 202 reports (10.09%)
- Product Use In Unapproved Indication — 176 reports (8.79%)
- Fatigue — 36 reports (1.8%)
- Headache — 35 reports (1.75%)
ALMOTRIPTAN MALATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is ALMOTRIPTAN MALATE approved in United States?
Yes. FDA authorised it on 7 July 2015; FDA authorised it on 9 November 2015; FDA authorised it on 3 March 2016.
Who is the marketing authorisation holder for ALMOTRIPTAN MALATE in United States?
TEVA PHARMS USA holds the US marketing authorisation.