Alembic Pharma receives final USFDA nod for Docetaxel Injection USP by admin- Wednesday, March 1st, 2023 03:22:30 PM
Alembic Pharmaceuticals obtained very last approval from the USA Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) SingleDose Vial, and 80 mg/8 mL (10 mg/mL) and 160 mg/16 mL (10 mg/mL) Multiple-Dose Vials. The accredited ANDA is therapeutically equivalent to the reference listed drug product (RLD), Docetaxel Injection, 20 mg/2 mL, eighty mg/eight mL, and 160 mg/sixteen mL (10
mg/mL), of Hospira, Inc. Docetaxcel Injections are indicated for the breast cancer, nonsmall mobile lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous mobile carcinoma of head and neck. Refer to our label for complete indication.