The US Food and Drug Administration (FDA) has approved Sun Pharmaceutical Industries' abbreviated new drug application (ANDA) for Doxorubicin HCl Liposome Injection USP, 2 mg/ml.
Doxorubicin HCl Liposome Injection USP, 2 mg/ml, which is generic equivalent to Janssen Research and Development's Doxil Liposome Injection, 2 mg/mL, is indicated for use in patients with ovarian cancer that has progressed or recurred after platinum-based chemotherapy.
Doxorubicin HCl Liposome Injection USP, 2mg/mL will be available in 20 mg/10mL and 50 mg/25mL single-use vials, claims the company.
Sun Pharmaceutical said the application was submitted to the FDA by its subsidiary.
Source:
http://drugdelivery.pharmaceutical-business-review.com/news/fda-approves-sun-pharma-anda-for-generic-doxil-060213
