naratriptan

FDA Drug Profile — naratriptan

Drug Details

Generic Name
naratriptan
Brand Names
naratriptan
Application Number
ANDA200502
Sponsor
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC Codes
2
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
NARATRIPTAN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Naratriptan is indicated for the acute treatment of migraine attacks 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 to the first migraine attack treated with naratriptan, reconsider the diagnosis of migraine before naratriptan is administered to treat any subsequent attacks. • Naratriptan is not indicated for the prevention of migraine attacks. • Safety and effectiveness of naratriptan have not been established for cluster headache. Naratriptan 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 if a clear diagnosis of migraine has been established. ( 1 ) • Not indicated for the prophylactic therapy of migraine attacks. ( 1 ) • Not indicated for the treatment of cluster headache. ( 1 )