Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Methotrexate Injection USP

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) SingleDose 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: i) Acute Lymphoblastic Leukemia, ii) Meningeal Leukemia: Prophylaxis and Treatment, iii) Non-Hodgkin Lymphoma, iv) Osteosarcoma, v) Breast Cancer, vi) Squamous Cell Carcinoma of the Head and Neck, and vii) Gestational Trophoblastic Neoplasia. It is also indicated for the treatment of: i) rheumatoid arthritis (RA), ii) polyarticular juvenile idiopathic arthritis (pJIA), and iii) 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.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 734.95 as compared to the previous close of Rs. 719.20. The total number of shares traded during the day was 20606 in over 4267 trades.

The stock hit an intraday high of Rs. 740.25 and intraday low of 720.00. The net turnover during the day was Rs. 15041213.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval MethotrexateInjection