frovatriptan succinate

FDA Drug Profile — frovatriptan succinate, FROVATRIPTAN

Drug Details

Generic Name
frovatriptan succinate
Brand Names
frovatriptan succinate, FROVATRIPTAN
Application Number
ANDA204730
Sponsor
Glenmark Pharmaceuticals Inc., USA
NDC Codes
3
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
FROVATRIPTAN SUCCINATE

Indications and Usage

1 INDICATIONS AND USAGE Frovatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use • Use only if a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with frovatriptan succinate tablets, reconsider the diagnosis of migraine before frovatriptan succinate tablets are administered to treat any subsequent attacks. • Frovatriptan succinate tablets are not indicated for the prevention of migraine attacks. • Safety and effectiveness of frovatriptan succinate tablets have not been established for cluster headache. Frovatriptan succinate is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use • Use only after a clear diagnosis of migraine has been established ( 1 ) • Not indicated for the prophylactic therapy of migraine ( 1 ) • Not indicated for the treatment of cluster headache ( 1 )