Revision Year: 2023
Palovarotene is an orally bioavailable retinoid that acts as a retinoic acid receptor (RAR) agonist with particular selectivity at the gamma subtype of RAR. Palovarotene is chemically described as 4-[(E)2(5,5,8,8-tetramethyl-3-pyrazol-1-ylmethyl-5,6,7,8-tetrahydro-naphthalen-2-yl)-vinyl]-benzoic acid with an empirical formula of C27H30N2O2 and has a molecular weight of 414.54 g/mol.
The structural formula is represented below:
SOHONOS capsules are supplied in 1 mg, 1.5 mg, 2.5 mg, 5 mg and 10 mg strengths. Each capsule contains palovarotene as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule consists of gelatin and titanium dioxide. The black printing ink consists of black iron oxide, potassium hydroxide, propylene glycol and Shellac.
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SOHONOS is available in 5 strengths as an opaque white elongated size “0” hard-gelatin capsule, containing white to off-white powder. Table 4 shows capsules' strengths and imprints. Table 4. SOHONOS Capsules' Strengths and Imprints:
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SOHONOS is an opaque white elongated hard-gelatin capsule. SOHONOS is available in size “0” capsule and supplied as a blister strip containing 14 capsules in a child resistant carton. Capsule contains white to off-white powder. Table 8 shows capsules' strengths, imprints, and NDC numbers. Table 8. Capsules' Strengths, Imprints, and NDC numbers:
Distributed by: Ipsen Biopharmaceuticals, Inc. Cambridge, MA; 02142 |
| Drug | Countries | |
|---|---|---|
| SOHONOS | United States |
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