US FDA approval is an outcome of extensive collaboration with the company’s partner, Natco Pharma, on R&D and manufacturing capabilities
Dr Reddy’s Laboratories (DRL) has received approval from the US Food and Drug Administration (US FDA) to launch doxorubicin hydrochloride liposome injection, a therapeutic equivalent generic version of Doxil (doxorubicin hydrochloride liposome injection), for intravenous use, in the US market. US FDA approval is an outcome of extensive collaboration with the company’s partner, Natco Pharma, on R&D and manufacturing capabilities.
“This approval represents the first-of-its-kind for DRL’s in the complex depot injectables arena,” explains Alok Sonig, Executive VP and Head of the North America Generics business, DRL. “It is 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.”
“We are pleased with our partnership with DRL. This approval would not have been possible without their guidance and support,” says Rajeev Nannapaneni, VC and CEO, Natco Pharma.
The Doxil brand and generic had US sales of approximately $196 million MAT for the most recent twelve months ending in March 2017 according to IMS Health.