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Aurobindo Receives FDA Approval for Isotretinoin Capsules USP, 20 mg, 30 mg, and 40 mg

Published: September 10, 2026

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Isotretinoin Capsules USP, 20 mg, 30 mg, and 40 mg. Aurobindo Pharma’s Isotretinoin Capsules USP, are an AB-rated generic equivalent to the reference listed drug (RLD), Accutane® Capsules, manufactured by Hoffmann La Roche Inc.

Isotretinoin Capsules are indicated for the:

  • Treatment of severe recalcitrant nodular acne.