Alembic Pharma gets USFDA nod for Methotrexate Injection USP, 50 mg/2 mL multi-dose vials and 1g/40 mL single-dose vials
Methotrexate Injection is a folate analog metabolic inhibitor indicated for neoplastic diseases
Alembic Pharmaceuticals 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) SingleDose 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.
Alembic has a cumulative total of 236 ANDA approvals (218 final approvals and 18 tentative approvals) from USFDA.