Alembic Pharmaceuticals received final USFDA approval for its generic Methotrexate Injection USP, used to treat cancer and autoimmune diseases.
The approved ANDA is equivalent to the reference drug from Hospira, Inc., covering two vial strengths for multi-dose and single-dose use.
This approval brings Alembic's cumulative ANDA approvals from the USFDA to 236, comprising 218 final and 18 tentative approvals.