FDA approves Launch of Doxorubicin Hydrochloride Liposome Injection in the U.S. Market

Dr. Reddy’s Laboratories Ltd. announced that USFDA has approved to launch Doxorubicin Hydrochloride Liposome Injection for intravenous use, in the US market. The approval is an outcome of extensive collaboration with Natco Pharma Ltd. on R&D and manufacturing capabilities. Doxorubicin Hydrochloride Liposome Injection is an therapeutic equivalent generic version of  ALZA Corporation’s Doxil.

Alok Sonig, Executive VP and Head of the NA Generics business at Dr. Reddy’s Laboratorie said that this approval represents the first of its kind for Dr. Reddy’s in the complex depot injectables arena. It is a testament to their commitment to bring affordable generic medicines to market for patients. The approval further validates their capabilities to successfully develop and manufacture complex liposomal formulations. They are preparing for a commercial launch soon.

Natco Pharma Vice Chairman and CEO, Rajeev Nannapaneni said that they are pleased with their partnership with Dr. Reddy’s Laboratories. This approval would not have been possible without their guidance and support.

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. The following individually cartoned vials are available:

mg in

vial

fill

volume

vial size
20 mg

vial

10-mL 10-mL
50 mg

vial

25-mL 30-mL
WARNING: CARDIOMYOPATHY and INFUSION RELATED REACTIONS
See full prescribing information for complete boxed warning.
  • Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550 mg/m2. The risk of cardiomyopathy may be increased at lower cumulative doses with mediastinal irradiation.
  • Acute infusion-related reactions occurred in 11% of patients with solid tumors. Serious, life-threatening, and fatal infusion reactions have been reported. Medications/emergency equipment to treat such reactions should be available for immediate use.
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