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