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 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 to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks. Naratriptan tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of naratriptan tablets have not been established for cluster headache. Naratriptan Tablets are serotonin (5-HT 1B/1D ) receptor agonists (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)