USFDA clears Dr Reddy's ovarian cancer generic sale

Evrard Martin
Mai 18, 2017

Doxorubicin hydrochloride liposome injection is a therapeutic equivalent generic version of Doxil® (doxorubicin hydrochloride liposome injection).

Dr.Reddy's Laboratories Ltd (ADR) (NYSE:RDY) disclose that it received FDA approval for introducing Doxorubicin Hydrochloride Liposome Injection in the United States. 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.

"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 product is indicated to treat ovarian cancer.

The Doxil brand and generic had US sales of approximatedly $196 million MAT for the twelve months ended March 2017, according to IMS Health. "It is a testament to our commitment to bring affordable generic medicines to market for patients".

The injection comes in single dose vials of 10 ml or 30 ml, it added.

Natco Pharma Vice Chairman and CEO Rajeev Nannapaneni said that the company is pleased with its partnership with DRL and that the approval from USFDA would not have been possible without their guidance and support.

Shares of the company gained Rs 13.9, or 0.51%, to trade at Rs 2,737.00.

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