Dr. Reddy’s Laboratories (NYSE:RDY) said today that the FDA approved its doxorubicin hydrochloride liposome injection for intravenous administration.
The liposomal formulation is a therapeutic-equivalent generic version of the chemotherapeutic, Doxil.
“This approval represents the 1st of its kind for Dr. Reddy’s in the complex depot injectables arena,” Alok Sonig, executive VP and head of the U.S. generics biz, said in prepared remarks. “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,” Natco Pharma vice chairman and CEO Rajeev Nannapaneni added.
RDY shares were trading at $41.92 in mid-afternoon activity today, down -1%.
