sumatriptan succinate

FDA Drug Profile — SUMATRIPTAN SUCCINATE, sumatriptan succinate, Sumatriptan Succinate, Onzetra Xsail

Drug Details

Generic Name
sumatriptan succinate
Brand Names
SUMATRIPTAN SUCCINATE, sumatriptan succinate, Sumatriptan Succinate, Onzetra Xsail
Application Number
ANDA213518
Sponsor
Mylan Pharmaceuticals Inc.
NDC Codes
25
Dosage Forms
TABLET, FILM COATED, INJECTION, CAPSULE
Routes
SUBCUTANEOUS, ORAL, NASAL
Active Ingredients
SUMATRIPTAN SUCCINATE

Indications and Usage

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