Global pharma major Lupin Limited (Lupin) announced that its alliance partner, ForDoz Pharma Corporation, USA (ForDoz) has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials, to market a generic equivalent of Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation.

Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials are indicated for treatment of ovarian cancer, acquired immune deficiency syndrome (AIDS)-related Kaposi’s Sarcoma, and multiple myeloma.

Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024).