American Society of Hematology

FDA Update on Availability of Doxorubicin Hydrochloride Liposome Injection

Published on: October 07, 2013

In collaboration with the Food and Drug Administration (FDA), and as a service to our members, ASH provides information about newly approved therapies for patients. This allows the agency to inform hematologists and professionals in hematology-related fields of recent approvals in a timely manner. Included in the message below is a link to the product label, which provides the relevant clinical information on the indication, contraindications, dosing, and safety. In providing this information, ASH does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described. The following is a message from the FDA’s Office of Hematology and Oncology Products:

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:

Sun Pharma Global FZE
(Caraco Pharmaceutical, U.S. distributor)
1-888-835-2237
2 mg/mL; 10 mL  vial
(NDC 47335-049-40)

2 mg/ml; 25 mL vial
(NDC 47335-050-40)
Janssen Products, LP
1-800-526-7736
(1-800-JANSSEN)
Doxil 2 mg/mL, Janssen Products, LP
2 mg/mL, 10 mL (20 mg) vial (NDC 59676-0960-01)

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 http://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).

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