Alembic Pharmaceuticals (Alembic) announced today that it has received final FDA approval for its Abbreviated New Drug Application (ANDA) Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) Single Dose Vial, as well as 80 mg/8 mL (10 mg/mL) and 160 mg/16 mL (10 mg/mL) Multiple-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Docetaxel Injection, 20 mg/2 mL, 80 mg/8 mL, and 160 mg/16 mL (10 mg/mL), of Hospira, Inc.
Docetaxcel Injections are approved for the treatment of breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma, and head and neck squamous cell carcinoma. According to IQVIA, the market for Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) Single-Dose Vials, as well as 80 mg/8 mL (10 mg/mL) and 160 mg/16 mL (10 mg/mL) Multiple-Dose Vials, is worth US$ 11 million in the twelve months ending December 2022.