Mumbai, Apr 16: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Methotrexate Injection USP, 50 mg/2 mL (25 mg/mL) Multi-Dose Vials & 1g/40 mL (25 mg/mL) Single-Dose Vials.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Methotrexate Injection USP, 50 mg/2 mL (25 mg/mL) Multi- Dose Vials & 1g/40 mL (25 mg/mL) Single-Dose Vials, of Hospira, Inc. Methotrexate Injection is a folate analog metabolic inhibitor indicated for neoplastic diseases:
- Acute Lymphoblastic Leukemia,
- Meningeal Leukemia: Prophylaxis and Treatment,
- Non-Hodgkin Lymphoma,
- Osteosarcoma,
- Breast Cancer,
- Squamous Cell Carcinoma of the Head and Neck, and
- Gestational Trophoblastic Neoplasia.
It is also indicated for the treatment of:
- rheumatoid arthritis (RA),
- polyarticular juvenile idiopathic arthritis (pJIA), and
- severe psoriasis. Refer label for a detailed indication.
Alembic has a cumulative total of 236 ANDA approvals (218 final approvals and 18 tentative approvals) from USFDA.
