Dr Reddys Labs relaunches Zenatane-generic version of Accutane in US

Written by Farhat Nasim Published On 2019-06-04T11:52:52+05:30 | Updated On 4 Jun 2019 11:52 AM IST

Dr Reddys Labs relaunches Zenatane-generic version of Accutane in US

Zenatane (lsotretinoin Capsules, USP), 10 mg, 20 mg, 30 mg and 40 mg is being launched with an approved Risk Evaluation and Mitigation Strategy (REMS) Program. The product is a therapeutic equivalent generic version of Accutane.

New Delhi: Hyderabad-based Dr Reddy's Laboratories Ltd. (Dr Reddy’s) recently announced the relaunch of Zenatane (lsotretinoin Capsules, USP), 10 mg, 20 mg, 30 mg and 40 mg a therapeutic equivalent generic version of Accutane, approved by the U.S. Food and Drug Administration (USFDA).

Accutane capsule is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment.

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

Explaining about the re-launch, Marc Kikuchi, Chief Executive Officer, North America Generics said, "We're pleased to bring this important product back to the 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."

"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 U.S. market, " he added.

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

Dr Reddy's Zenatane (lsotretinoin Capsules, USP) are available in 3x10 (30-count) blister packages of 10 mg, 20 mg 30 mg, and 40 mg Capsules, USP.

DRL was founded by Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited, of Hyderabad, India.

Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products - Dr Reddy's offers a portfolio of products and services including APIs, custom
pharmaceutical services, generics, biosimilars and differentiated formulations. The major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. DRL operates in markets across the globe.

Also Read: Dr Reddys launches Tadalafil tablets for treating erectile dysfunction

AccutaneacneCardiovascularcystic acneDermatologydiabetologyDr Reddy'sDr Reddy's LaboratoriesDr Reddy's LabsDRLgastrointestinalHyderabadlsotretinoinlsotretinoin Capsulesnodular acneoncologyREMSRisk evaluationsevere acneUS marketUSFDAZenatane

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Farhat Nasim

Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here