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Aurobindo receives FDA approval for isotretinoin capsule

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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. Aurobindo Pharma’s isotretinoin capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Absorica Capsules manufactured by Sun Pharmaceutical Industries.

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 5mm or greater.

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


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