frovatriptan succinate

FDA Drug Profile — FROVATRIPTAN, frovatriptan succinate

frovatriptan succinate is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including FROVATRIPTAN, frovatriptan succinate. Available dosage form: tablet, film coated.

Drug Details

Generic Name
frovatriptan succinate
Brand Names
FROVATRIPTAN, frovatriptan succinate
Application Number
ANDA213891
Sponsor
Ingenus Pharmaceuticals, LLC
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 )