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These highlights do not include all the information needed to use CLARAVIS safely and effectively. See full prescribing information for CLARAVIS. CLARAVIS™ (isotretinoin capsules), for oral use Initial U.S. Approval: 1982
Medication labelWhy this: Advisory · dailymed-prescription
Claravis™ (isotretinoin capsules USP) is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Claravis is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use: If a second course of Claravis treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration (2.2)].
- generic_name
- isotretinoin
- product_names
- Isotretinoin
- ndc
- 0555-1054, 0555-1054-60, 0555-1054-86, 0555-1054-56, 0555-1055, 0555-1055-60, 0555-1055-86, 0555-1055-56, 0555-1056, 0555-1056-60, 0555-1056-86, 0555-1057, 0555-1057-60, 0555-1057-56, 0555-1057-86
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en