USFDA clears Dr Reddy's ovarian cancer generic sale

Barsaba Taglieri
Mag 18, 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, for intravenous use, in the US market. The USFDA approval is an outcome of extensive collaboration with the company's partner, Natco Pharma Limited, on R&D and manufacturing capabilities, it also said.

The product is indicated to treat ovarian cancer. The company pointed out that the Doxil brand, as well as, generic generated sales of about $196 million MAT for the recent twelve-month period ended March 2017 in the United States.

"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. The approval further validates our capabilities to successfully develop and manufacture complex liposomal formulations.

Hyderabad-based Dr Reddy's is preparing for a commercial launch soon.

The injection comes in single dose vials of 10 ml or 30 ml, it added. "This approval would not have been possible without their guidance and support", said Rajeev Nannapaneni, vice chairman and CEO, Natco Pharma.

Shares of DRL were trading at Rs 2,743.20 apiece in the afternoon trade, up 0.74 per cent, from the previous close on the BSE.

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