Dr. Reddy’s earns FDA approval for Doxil generic

PRINCETON, N.J. — Dr. Reddy’s Laboratories announced on Wednesday that it has received Food and Drug Administration approval to launch doxorubicin hydrochloride liposome injection, a therapeutic equivalent generic version of Janssen Products’ Doxil (doxorubicin hydrochloride liposome injection), for intravenous use, in the United States market.

The product is indicated to treat ovarian cancer.

According to Dr. Reddy’s, FDA approval is an outcome of extensive collaboration with the company’s partner, Natco Pharma on research and develop and manufacturing capabilities.

“This approval represents the first of its kind for Dr. Reddy’s in the complex depot injectables arena,” said Alok Sonig, EVP 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.”

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.

“We are pleased with our partnership with Dr.Reddy’s Laboratories. This approval would not have been possible without their guidance and support,” said Rajeev Nannapaneni, vice chairman and CEO, Natco Pharma.

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