Pharma major Dr Reddy’s Laboratories has announced the re-launch of Zenatane (Isotretinoin Capsules), a therapeutic equivalent generic version of Accutane, approved by the US Food and Drug Administration (USFDA).

The product is being launched with an approved Risk Evaluation and Mitigation Strategy (REMS) Programme.

“We’re pleased to bring this 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,” Marc Kikuchi, Chief Executive Officer, North America Generics, said.

“Furthermore, this is important for our company as we have commercialised 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,” he said.

The Zenatane brand and generic had sales of approximately $525 million in the US for the most twelve months ending in March 2019, according to IQVIA Health.

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