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Dr Reddy’s announces the re-launch of Zenatane in the US Market

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Zenatane is a generic version of Accutane by Hoffman LaRoche

Dr Reddy’s Laboratories has announced the re-launch of Zenatane (Isotretinoin Capsules, USP), 10 mg, 20 mg, 30 mg and 40 mg, a therapeutic equivalent generic version of Accutane by Hoffman LaRoche, approved by the US Food and Drug Administration (US FDA). The product is being launched with an approved Risk Evaluation and Mitigation Strategy (REMS) Program.

“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 market place,” explains Marc Kikuchi, Chief Executive Officer, North America Generics, adding, “Furthermore, this is important for our company as we have commercialized the first Softgel dosage product from Dr Reddy’s own manufacturing plant to ensure consistent and robust supply for this product in the US market.”

The Zenatane (Isotretinoin Capsules, USP), 10 mg, 20 mg, 30 mg and 40 mg brand and generic had US sales of approximately $525 million MAT for the most recent twelve months ending in March 2019 according to IQVIA Health.

Dr Reddy’s Zenatane (Isotretinoin Capsules, USP) are available in 3×10 (30-count) blister packages of 10 mg, 20 mg 30 mg, and 40 mg Capsules, USP.

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