REYVOW Tablet Ref.[10110] Active ingredients: Lasmiditan

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

REYVOW (lasmiditan) is a serotonin (5-HT) 1F receptor agonist for oral administration. The chemical name of lasmiditan hemisuccinate is 2,4,6-trifluoro-N-[6-(1-methylpiperidine-4-carbonyl)pyridine-2-yl]benzamide hemisuccinate. It has the empirical formula of C19H18F3N3O2•0.5[C4H6O4] and a molecular weight of 436.41 (hemisuccinate).

Lasmiditan hemisuccinate has the following structural formula:

Lasmiditan hemisuccinate is a white, crystalline powder that is sparingly soluble in water, slightly soluble in ethanol, and soluble in methanol. A 1 mg/mL aqueous solution of lasmiditan hemisuccinate has a pH of 6.8 at ambient conditions.

REYVOW 50 mg tablets contain 50 mg lasmiditan (equivalent to 57.824 mg lasmiditan hemisuccinate) and the inactive ingredients as follows:

Excipients – croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate.

Color mixture ingredients – black ferric oxide, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

REYVOW 100 mg tablets contain 100 mg lasmiditan (equivalent to 115.65 mg lasmiditan hemisuccinate) and the inactive ingredients as follows:

Excipients – croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate.

Color mixture ingredients – black ferric oxide, polyethylene glycol, polyvinyl alcohol, red ferric oxide, talc, titanium dioxide.

Dosage Forms and Strengths

REYVOW (lasmiditan) tablets are available in two strengths:

  • 50 mg tablet: light gray, oval, film coated, tablets with “L-50” debossed on one side and “4312” on the other
  • 100 mg tablet: light purple, oval, film coated, tablets with “L-100” debossed on one side and “4491” on the other
How Supplied

REYVOW (lasmiditan) 50 mg tablets are light gray, oval, film coated, tablets with “L-50” debossed on one side and “4312” on the other.

REYVOW (lasmiditan) 100 mg tablets are light purple, oval, film coated, tablets with “L-100” debossed on one side and “4491” on the other.

 Strengths
50 mg 100 mg
Tablet color Light gray Light purple
Imprint (debossed) L-50 4312 L-100 4491
Carton of 8 NDC 0002-4312-08 NDC 0002-4491-08

Drugs

Drug Countries
REYVOW Japan, United States

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