Silver Spring, MD (Official Notice) - FDA is providing in­­for­ma­tion on the avail­a­bil­ity of doxorubicin hydro­chlo­ride liposome injection to supply the U.S. market.

Doxil® (doxorubicin hydrochloride liposome injection) is distributed by Janssen Products, LP and has been manu­fac­tured under contract by Ben Venue Laboratories, Inc. On September 25, 2013, Janssen notified health­care professionals of an inter­rup­tion of supply of Doxil resulting from manu­fac­tur­ing issues at Ben Venue Laboratories. On October 3, 2013, Ben Venue Laboratories announced their plans to cease all manu­fac­tur­ing by the end of 2013.

Sun Pharma Global has con­firmed to FDA that there are sufficient supplies of its doxorubicin hydrochloride liposome injection, a generic prod­uct that is thera­peutically equivalent to Janssen’s Doxil, to cover the U.S. market. Please contact your wholesaler or the fol­low­ing customer service numbers to obtain prod­uct:

 
Doxil® is indicated for the treat­ment of ovarian cancer with disease pro­gres­sion after platinum-based chemo­ther­apy, AIDS-related Kaposi’s sarcoma in patients after failure of prior systemic chemo­ther­apy or intolerance to such ther­apy, and multiple myeloma in com­bi­na­tion with bor­tez­o­mib in patients who have not pre­vi­ously received bor­tez­o­mib and have received at least one prior ther­apy.

Sun Pharma Global’s doxorubicin hydrochloride liposome injection is indicated for the treat­ment of ovarian cancer with disease pro­gres­sion after platinum-based chemo­ther­apy and for AIDS-related Kaposi’s sarcoma in patients after failure of prior systemic chemo­ther­apy or intolerance to such ther­apy.

Healthcare professionals should report all serious adverse events sus­pected to be asso­ci­ated with the use of any medicine and device to FDA’s MedWatch Reporting System by com­plet­ing a form online at www.fda.gov/medwatch/report.htm , by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

Source: U.S. Food and Drug Admin­istra­tion.