Dr Reddy's Labs receives US FDA nod for doxorubicin injection

Dr Reddy’s Laboratories Ltd (DRL) has received approval from the US Food and Drug Administration (FDA) to launch doxorubicin hydrochloride liposome injection for intravenous use in the US market. DRL had partnered with Natco Pharma Ltd on R&D and manufacturing capabilities for developing the product, which is a generic version of Doxil (manufactured by Alza Corporation).

“This approval represents the first of its kind for Dr Reddy’s in the complex depot injectables arena. 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,” explained Alok Sonig, executive vice president and head of the North America Generics business at Dr Reddy’s Laboratories.