Alembic Pharmaceuticals announced that it has received final approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection. The approval includes 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials.
The product is therapeutically equivalent to the reference listed drug (RLD), Doxil Liposome Injection, in the same strengths, marketed by Baxter Healthcare Corporation.
According to the company, Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma. Alembic advised that users refer to the approved label for the detailed indication.
The estimated market size for Doxorubicin Hydrochloride Liposome Injection in the strengths approved is approximately US$ 29 million for the twelve-month period ending March 2025, as per data from IQVIA.
With this approval, Alembic now has a cumulative total of 224 ANDA approvals from the USFDA, comprising 201 final approvals and 23 tentative approvals.