Pharmaceutical Business review

FDA approves Sun Pharma ANDA for generic Doxil

Doxorubicin HCl Liposome Injection USP, 2 mg/ml, which is generic equivalent to Janssen Research and Developmentā€™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.