Dr Reddy’s gets USFDA nod for doxorubicin hydrochloride liposome injection

Our Bureau Hyderabad | Updated on January 11, 2018 Published on May 17, 2017

Pharma major Dr Reddy’s Laboratories Ltd has received approval from the US Food and Drug Administration (USFDA) to launch doxorubicin hydrochloride liposome injection.

The approved drug is a therapeutic equivalent generic version of Doxil (doxorubicin hydrochloride liposome injection), for intravenous use, in the US market.

The USFDA approval is an outcome of collaboration with the company’s partner, Natco Pharma Ltd, on R&D and manufacturing capabilities.

“This approval represents the first of its kind for Dr. Reddy’s in the complex depot injectables arena,” Alok Sonig, Executive Vice-President and Head of North America Generics business at Dr. Reddy’s Laboratories, said in a release issued here on Wednesday.

Hyderabad-based Dr Reddy’s is preparing for a commercial launch soon. Tha drug is indicated for patients suffering from certain types of cancer.

“We are pleased with our partnership with Dr.Reddy’s Laboratories. This approval would not have been possible without their guidance and support,” Rajeev Nannapaneni, Vice Chairman and Chief Executive Officer, Natco Pharma, said.

The Doxil brand and generic had US sales of approximately $196 million for the most recent twelve months ended in March 2017, according to IMS Health.

Dr Reddy’s scrip was trading up by 0.44 per cent Rs 2, 735 on the BSE.

Published on May 17, 2017
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