Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) single-dose vial, and 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. Docetaxcel Injections are indicated for breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of the head and neck.
Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) Single-Dose Vial, and 80 mg/8 mL (10 mg/mL) and 160 mg/16 mL (10 mg/mL) Multiple-Dose Vials, have an estimated market size of US$ 11 million for twelve months ending Dec 2022 according to IQVIA.
Alembic has a cumulative total of 181 ANDA approvals (158 final approvals and 23 tentative approvals) from US FDA.