Alembic Pharmaceuticals Ltd. on Wednesday announced that it has received final approval from the US drug regulator for single-dose and multiple-dose vials of Docetaxel Injection USP which is therapeutically equivalent to the reference listed drug product (RLD) of Hospira, Inc.
In a filing to the stock exchanges, the company said that the United States Food and Drug Administration (USFDA) has given final approval to 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.
Docetaxel is a member of a family of drugs called taxanes. It works by slowing cell growth.
Alembic Pharma said that Docetaxel 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 $11 million for the 12 months ending in December 2022, according to IQVIA data.
The Vadodra-based pharma company said that it now has a cumulative total of 181 ANDA approvals (158 final approvals and 23 tentative approvals) from the USFDA.
Last month, it received tentative approval from the USFDA for Acalabrutinib Capsules, 100 mg, used in the treatment of mantle cell lymphoma (MCL) in adults who have received at least one previous treatment for their cancer. Mantle cell lymphoma is a type of blood cancer that affects white blood cells.
