Source: FDA, National Drug Code (US) Revision Year: 2018
FROVA (frovatriptan succinate) tablets contain frovatriptan succinate, a selective 5-hydroxy-tryptamine1 (5-HT1B/1D) receptor subtype agonist (triptan), as the active ingredient. Frovatriptan succinate is chemically designated as R-(+) 3-methylamino-6-carboxamido-1,2,3,4-tetrahydrocarbazole monosuccinate monohydrate and it has the following structure:
The empirical formula is C14H17N3O.C4H6O4.H2O, representing a molecular weight of 379.4. Frovatriptan succinate is a white to off-white powder that is soluble in water.
Each FROVA tablet for oral administration contains 3.91 mg frovatriptan succinate, equivalent to 2.5 mg of frovatriptan base. Each tablet also contains the inactive ingredients lactose NF, microcrystalline cellulose NF, colloidal silicon dioxide NF, sodium starch glycolate NF, magnesium stearate NF, hypromellose USP, polyethylene glycol 3000 USP, triacetin USP, and titanium dioxide USP.
| Dosage Forms and Strengths |
|---|
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2.5 mg Tablets: Round, white, film-coated tablets debossed with 2.5 on one side and “E” on the other side. |
| How Supplied |
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FROVA tablets, containing 2.5 mg of frovatriptan (base) as the succinate salt, are available as round, white, film-coated tablets debossed with 2.5 on one side and “E” on the other side. The tablets are available in: Blister card of 9 tablets, 1 blister card per carton (NDC 63481-025-09) Manufactured for: Endo Pharmaceuticals Inc., Malvern, PA 19355 Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK |
| Drug | Countries | |
|---|---|---|
| FROVA | Canada, United States |
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