Alembic Pharma Gets USFDA Nod For Doxorubicin Liposome Injection

Alembic Pharmaceuticals Ltd. has received final approval from the US Food and Drug Administration for its abbreviated new drug application for Doxorubicin Hydrochloride Liposome Injection, the company said in a press release.

The injection will be available in 20 mg/10 mL and 50 mg/25 mL single-dose vials, and is therapeutically equivalent to Doxil Liposome Injection by Baxter Healthcare Corp. It is indicated for the treatment of ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma. The approved drug had an estimated market size of $29 million for the year ended March, according to IQVIA data cited by Alembic.