The launch follows the FDA approval of the company’s ANDA for Zenatane 10mg, 20mg and 40mg.
Zenatane (Isotretinoin Capsules USP) is a generic version, therapeutically equivalent to Accutane (Isotretinoin Capsules USP).
Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne.
The company is making the product available in 10mg, 20mg, and 40mg strengths in boxes of 30 as unit dose blisters.