Dr. Reddy's gets USFDA approval for doxorubicin hydrochloride liposome injection
Pharma major Dr. Reddy\'s Laboratories Ltd has received approval from the US Food and Drug Administration (USFDA) to launch doxorubicin hydrochloride liposome injection, for intravenous use, in the US market.
Hyderabad: Pharma major Dr. Reddy's Laboratories Ltd has received approval from the US Food and Drug Administration (USFDA) to launch doxorubicin hydrochloride liposome injection, for intravenous use, in the US market.
Doxorubicin hydrochloride liposome injection is a therapeutic equivalent generic version of Doxil® (doxorubicin hydrochloride liposome injection).
The USFDA approval is an outcome of extensive collaboration with the company's partner, Natco Pharma Ltd. on R&D and manufacturing capabilities, the Hyderabad-based Dr Reddy's said in a statement on Wednesday.
"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," he said.
The Doxil® brand and generic had US sales of approximately $196 million MAT (moving annual total) for the recent 12 months ending in March 2017, according to IMS Health.
Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10-ml or 30-ml glass, single-dose vials.