Isotretinoin Generic Available Again for Severe Acne

Dr. Reddy’s has announced the relaunch of Zenatane (isotretinoin capsules) for the treatment of severe recalcitrant nodular acne unresponsive to conventional therapy (eg, systemic antibiotics).

Zenatane, a therapeutic equivalent to Accutane, is approved for marketing only under a special restricted distribution program (iPLEDGE) approved by the Food and Drug Administration (FDA), as it can cause severe birth defects. To prescribe and dispense Zenatane, prescribers and pharmacies must be registered in the iPLEDGE program; Zenatane may only be dispensed to patients who are also registered and meet all iPLEDGE requirements.

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The product is available in 10mg, 20mg, 30mg, and 40mg strength capsules and is supplied in 3×10 (30-count) blister packages. “We’re pleased to bring this important product back to market for the customers and patients who will benefit from access to this medicine and who have had witnessed limited supply and options in the marketplace,” said Marc Kikuchi, Chief Executive Officer, North America Generics.

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This article originally appeared on MPR