New Drug Approvals


1 APRIL, 2013

India-based Dr. Reddy’s Laboratories has announced the launch of Zenatane (Isotretinoin Capsules USP) in 20mg and 40mg strengths in the US.

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.

Isotretinoin, first marketed as Accutane byHoffmann-La Roche, is a medication used mostly for cystic acne. It is also achemotherapy treatment used in brain, pancreatic and other cancers. It is used to treat harlequin-type ichthyosis, a usually lethal skin disease, and lamellar ichthyosis. Its effects are systemic and nonselective. It is a retinoid, meaning it is related to vitamin A, and is found in small quantities naturally in the body.



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