U.S. FDA: Approved Drugs > Doxorubicin Hydrochloride Liposome (Injection)

Approved Drugs > Doxorubicin Hydrochloride Liposome (Injection)

 Doxorubicin Hydrochloride Liposome (Injection)
On February 4, 2013, the U. S. Food and Drug Administration approved doxorubicin hydrochloride liposome injection (Sun Pharma Global FZE), a generic version of DOXIL Injection (doxorubicin hydrochloride liposome; Janssen Products, L.P.) for the treatment of ovarian cancer in patients whose disease has progressed or recurred after platinum-based chemotherapy and for AIDS-related Kaposi’s sarcoma after failure of prior systemic chemotherapy or intolerance to such therapy.

 

FDA’s Office of Generic Drugs expedited the review of this generic application because of the drug shortage for DOXIL. DOXIL is under drug shortage because of manufacturing issues.......