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, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg. Aurobindo Pharma’s Isotretinoin Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Absorica® Capsules manufactured by Sun Pharmaceutical Industries, Inc.

Isotretinoin Capsules are indicated for:

• The treatment of severe recalcitrant nodular acne in nonpregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater.