Aurobindo given FDA approval for Isotretinoin Capsules

Aurobindo received final approval from the Food and Drug Administration for its abbreviated new drug application—Isotretinoin Capsules. 

The Isotretinoin Capsules manufactured by the company are an AB-rated generic equivalent to the reference listed drug, Absorica Capsules (manufactured by Sun Pharmaceutical Industries).

Isotretinoin Capsules are indicated for the treatment of severe recalcitrant nodular acne in nonpregnant patients aged 12 years old and older with multiple inflammatory nodules with a diameter of 5mm or greater.

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Aurobindo’s Isotretinoin Capsules will be available in 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg. 

Isotretinoin Capsules have an estimated market size of US $315 Million for the twelve months ending Nov 2023, as per IQVIA.