Dr Reddy's gets USFDA nod to launch new ovarian cancer drug in US

Alza Corporation's Doxil injection had sales of $196 mn in the 12 months ended March 2017

Hyderabad-based Dr Reddy's Laboratories has received approval from US Food and Drug Administration (US FDA) to launch Doxorubicin Hydrochloride Liposome injection in the US market. 

This product is the therapeutic equivalent generic version of Doxil, a chemotherapy drug which is used in the treatment of certain types of cancer such as ovarian cancer, AIDS-related Kaposi's sarcoma and multiple myeloma. It is meant for intravenous use in slowing or stopping cancer cell growth. The US FDA approval was an outcome of extensive collaboration with the company's partner Natco Pharma Limited, on R&D and manufacturing capabilities, according to Dr Reddy's. 

"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 the North America generics business at Dr Reddy's, said. "The approval further validates our capabilities to successfully develop and manufacture complex liposomal formulations. We are preparing for a commercial launch soon."

Doxil brand and generic had US sales of approximately $196 million moving annual turnover for year ended March, going by IMS Health data. "We are pleased with our partnership with Dr Reddy's Laboratories. The approval would not have been possible without their guidance and support,"said Rajiv Nannapaneni, vice-chairman and chief executive officer of Natco Pharma.

As part of an agreement with Natco Pharma, Dr Reddy's sells its oral and injectable generic oncology drugs across the globe. Both the companies together developed Doxorubicin Hydrochloride Liposome injection for commercialisation in the US market. Doxorubicin Hydrochloride Liposome injection is a sterile, translucent, red liposomal dispersion in 10 ml or 30 ml glass, single-dose vials. Each 10 ml vial contains 20 mg Doxorubicin Hydrochloride, while each 30 ml vial contains 50 mg Doxorubicin Hydrochloride at a concentration of 2 mg per ml, Dr Reddy’s said.