Dr Reddy's Generic Doxil Gets US FDA Nod

Dr Reddy's Laboratories Ltd. has received approval from the US Food and Drug Administration (FDA) to launch doxorubicin hydrochloride liposome injection, a therapeutic equivalent generic version of Doxil (doxorubicin hydrochloride liposome injection), for intravenous use, in the United States market. The US FDA approval is an outcome of extensive collaboration with the company's partner, Natco Pharma Ltd., on R&D and manufacturing capabilities.

"This approval represents the first of its kind for Dr Reddy'\'s in the complex depot injectables arena," explains Alok Sonig, executive vice president and head of the North America generics business at Dr Reddy's Laboratories. "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 Dr Reddy's Laboratories. This approval would not have been possible without their guidance and support," says Rajeev Nannapaneni, vice chairman and chief executive officer, Natco Pharma.

The Doxil brand and generic had US sales of approximately USD 196 million MAT for the most recent twelve months ending in March 2017 according to IMS Health.

Dr Reddy's 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 at a concentration of 2 mg/mL. Each 30-mL vial contains 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL.

Doxil is a registered trademark of ALZA Corporation.