Source: FDA, National Drug Code (US) Revision Year: 2023
SKYCLARYS contains omaveloxolone in immediate release capsules for oral administration available in a 50 mg strength. The chemical name of omaveloxolone is N-(2-cyano-3,12-dioxo-28-noroleana-1,9(11)-dien-17-yl)-2,2-difluoro-propanamide. Omaveloxolone is a white to off-white amorphous solid. The molecular formula is C33H44F2N2O3. Molecular weight is 554.72 g/mol.
The chemical structure is:
Omaveloxolone has a pKa of 7.26 and is practically insoluble in water across the physiological pH range. Capsule contents include the following inactive ingredients: croscarmellose sodium, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The hard capsule shells contain FD&C Blue #1, ferric oxide yellow, hypromellose, titanium dioxide, and white ink.
| Dosage Forms and Strengths |
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SKYCLARYS capsules contain 50 mg of omaveloxolone, and are supplied as opaque hard capsules having a light green body and blue cap, imprinted with “RTA 408” in white ink on the body and “50” in white ink on the cap. |
| How Supplied |
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SKYCLARYS (omaveloxolone) capsules, 50 mg, are supplied as opaque, hard capsules having a light green body and blue cap imprinted with “RTA 408” in white ink on the body and “50” in white ink on the cap. SKYCLARYS is supplied in high density polyethylene bottles that contain 90 capsules, with a foil induction seal and child-resistant closure (NDC 73179-250-90). Manufactured for Reata Pharmaceuticals, Inc., Plano, TX 75024 USA |
| Drug | Countries | |
|---|---|---|
| SKYCLARYS | Austria, Estonia, France, Croatia, Lithuania, United States |
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