Alembic Pharmaceuticals receives USFDA approval for Methotrexate Injection
India, April 16 -- Alembic Pharmaceuticals (Alembic) 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: i) Acute Lymphoblastic Leukemia, ii) Meningeal Leukemia: Prophylaxis and Treatment, iii) Non-Hodgkin Lymphoma, iv) Osteosarcoma, v) Bre...
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