US FDA Approves Teva Anti-Inflammatory ANDA

Leading Israeli generics maker Teva has announced that the US FDA has given final approval for its ANDA on the company's methylprednisolone acetate injectable suspension. The product, to be distributed in 40- and 80-mg/mL single-dose vials, is an AP-rated generic equivalent of Depo-Medrol injection, marketed by US drug major Pfizer. Depo-Medrol is a glucocorticoid indicated for intramuscular, intrasynovial, soft tissue or intralesional injection.

Teva estimates the branded drug's annual sales at a relatively small US$41.4mn, although it claims to have roughly 140 pending US generic product applications, including 18 tentative approvals, with annual branded equivalent sales exceeding US$82bn.