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Dr Reddy’s gets FDA nod for anti-cancer drug
Dr Reddy’s Laboratories (DRL) has received approval from the US health regulator USFDA for marketing its generic version of Alza Corporation’s Doxil injection used for treatment of ovarian cancer.
Hyderabad: Dr Reddy’s Laboratories (DRL) has received approval from the US health regulator USFDA for marketing its generic version of Alza Corporation’s Doxil injection used for treatment of ovarian cancer.
The US Food and Drug Administration’s (USFDA) approval for doxorubicin hydrochloride liposome intravenous injection is an outcome of extensive collaboration with the company’s partner Natco Pharma on research and development and manufacturing capabilities, according to a communiqué to BSE from Dr Reddy’s. It said that the injection comes in single dose vials of 10 ml or 30 ml.
Alok Sonig, Executive Vice-President and Head (North American Generics Business), Dr Reddy’s Lab, said: “It’s the first of its kind for the company. We’re preparing for a commercial launch soon. It's a testament to our commitment to bring affordable generic medicines to market for patients.
The approval further validates our capabilities to successfully develop and manufacture complex liposomal formulations. We are preparing for a commercial launch soon."
The drug major said that USFDA approval was an outcome of extensive collaboration with the company’s partner, Natco Pharma Ltd on R&D and manufacturing capabilities.
Rajeev Nannapaneni, Vice-Chairman and CEO, Natco Pharma, said: "We're pleased with our partnership with DrReddy's Laboratories. This approval would not have been possible without their guidance and support."
The Doxil brand and generic version had sales of about $196 million in the 12 months ended March 2017, Dr Reddy’s said citing IMS Health data. Meanwhile, Dr Reddy’s shares were up 8.85 percent to Rs2,731.97 on BSE.
