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.
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