USFDA approves Alembic Pharma anti-cancer injection Docetaxel
Docetaxel Injections are indicated for the breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of head and neck.
Mumbai: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company 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, Inc.
DocetaxelDocetaxel Injections are indicated for the breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of head and neck.
Read also: Alembic Pharma bags USFDA nod for mantle cell lymphoma drug Acalabrutinib
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 USFDA.
Medical Dialogues team had earlier reported that the company had received the final nod from the US Food & Drug Administration (USFDA) for its Abbreviated NewDrug Application (ANDA), Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per SingleDose Prefilled Syringe to treat breast cancer.
Read also: USFDA nod to Alembic Pharma breast cancer injection Fulvestrant
Headquartered in Vadodara, Gujarat, Alembic Pharmaceuticals Limited is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities. The company was founded in 1907. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
