Alembic Pharmaceuticals Limited has announced that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection in two strengths: 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials.
This product is the generic equivalent of Doxil Liposome Injection, the reference listed drug (RLD) manufactured by Baxter Healthcare Corporation. Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma. For detailed prescribing information and usage guidelines, healthcare professionals are advised to refer to the official label.
According to IQVIA data, the U.S. market for this product is estimated to be approximately USD 29 million for the twelve-month period ending March 2025.
With this approval, Alembic Pharmaceuticals now holds a cumulative total of 224 ANDA approvals from the USFDA, including 201 final approvals and 23 tentative approvals, reinforcing the company’s growing presence in the U.S. generics market.
