Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Methotrexate Injection USP. The approval covers both 50 mg/2 mL (25 mg/mL) multi-dose vials and 1g/40 mL (25 mg/mL) single-dose vials. This approval is for an Abbreviated New Drug Application (ANDA) and is therapeutically equivalent to the reference listed drug product by Hospira, Inc.
Methotrexate Injection is a folate analog metabolic inhibitor and is indicated for a range of neoplastic diseases including Acute Lymphoblastic Leukemia, Meningeal Leukemia for both prophylaxis and treatment, Non-Hodgkin Lymphoma, Osteosarcoma, Breast Cancer, Squamous Cell Carcinoma of the Head and Neck, and Gestational Trophoblastic Neoplasia. Additionally, it is approved for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and severe psoriasis.
Alembic Pharmaceuticals has achieved a cumulative total of 236 ANDA approvals from the USFDA, which includes 218 final approvals and 18 tentative approvals.
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company that has been a leader in healthcare since 1907. Headquartered in India, the company is publicly listed and is known for manufacturing and marketing generic pharmaceutical products globally. The company’s research and manufacturing facilities are approved by regulatory authorities in several developed countries, including the USFDA.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).