Alembic Pharma Announces USFDA Approval For Docetaxel Injection
Alembic Pharmaceuticals on Wednesday said that it has received final approval from the US Food and 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 company said in a regulatory filing.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Docetaxel Injection, of Hospira, Inc. The Injections are indicated for breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of head and neck.
Docetaxel Injection 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 the USFDA.
The company's stock was trading 1.47 per cent higher on Wednesday at Rs 61.95 per scrip as of 12:03 Indian Standard Time.
