Doxorubicin

FDA Drug Profile — Doxorubicin Hydrochloride

Doxorubicin is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Doxorubicin Hydrochloride. Available dosage forms: powder, injection, powder, lyophilized, for solution.

Drug Details

Generic Name
Doxorubicin
Brand Names
Doxorubicin Hydrochloride
Application Number
ANDA208888
Sponsor
Meiji Seika Pharma Co., Ltd.
NDC Codes
2
Dosage Forms
POWDER, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
DOXORUBICIN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor indicated for: Ovarian cancer: After failure of platinum-based chemotherapy (1.1). AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy (1.2). Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy (1.3). 1.1 Ovarian Cancer Doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. 1.2 AIDS-Related Kaposi's Sarcoma Doxorubicin hydrochloride liposome injection is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. 1.3 Multiple Myeloma Doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.