Alembic Pharmaceuticals Receives US FDA Final Approval for Ciprofloxacin and Dexamethasone Otic Suspension

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for ciprofloxacin and dexamethasone otic suspension USP, 0.3 percent /0.1 percent.

The approved product is therapeutically equivalent to the reference listed drug, Ciprodex otic suspension, 0.3 percent /0.1 percent, marketed by Sandoz. It is indicated for treating Acute Otitis Media (AOM) in paediatric patients aged six months and older with tympanostomy tubes, and Acute Otitis Externa (AOE) in paediatric patients aged six months and older, adults and elderly patients. The treatment targets infections caused by susceptible isolates of designated microorganisms under the specified conditions.

According to IQVIA, the US market for ciprofloxacin and dexamethasone otic suspension USP, 0.3 percent/0.1 percent, was estimated at USD 110 million for the 12 months ending June 2026.

With this approval, Alembic Pharmaceuticals has a cumulative total of 246 ANDA approvals from the US FDA, comprising 226 final approvals and 20 tentative approvals.