OXBRYTA Film-coated tablet Ref.[9906] Active ingredients: Voxelotor

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

Product description

Voxelotor is a hemoglobin S polymerization inhibitor.

The chemical name of voxelotor is: 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde.

Voxelotor has a molecular formula of C19H19N3O3 and a molecular weight of 337.4.

The chemical structure of voxelotor is:

Voxelotor, the active drug substance, is a white-to-yellow-to-beige compound in crystalline Form II of its free base. It is non-hygroscopic. It is highly soluble in common organic solvents such as acetone and toluene and insoluble in water (approximately 0.03 mg/mL).

Each OXBRYTA film-coated tablet for oral use contains 500 mg of voxelotor with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. In addition, the film coating contains: polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.

Dosage Forms and Strengths

Tablets: 500 mg light yellow to yellow, oval shaped, biconvex, debossed with “GBT 500” on one side.

How Supplied

The 500 mg tablet is film-coated, light yellow to yellow, oval shaped, biconvex, debossed with “GBT 500” on one side, and available in:

  • Bottles of 90 tablets with child-resistant closure: NDC 72786-101-01

The bottle also contains one desiccant canister and one polyester coil. Do not eat.

Drugs

Drug Countries
OXBRYTA Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United States

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