Alembic Pharmaceuticals Ltd announced on Monday that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its generic drug, Ciprofloxacin and Dexamethasone Otic Suspension USP.
This medication is intended for the treatment of certain ear infections in children aged six months and older, as well as in adult and elderly patients.
The Abbreviated New Drug Application (ANDA) indicated that it is therapeutically equivalent to the reference listed drug (RLD) Ciprodex Otic Suspension, 0.3 per cent/0.1 per cent, manufactured by Sandoz Inc.
The drug is indicated for the treatment of infections caused by sensitive isolates of specific microorganisms under particular conditions. These include acute otitis media (AOM) in pediatric patients aged 6 months with tympanostomy tubes, as well as acute otitis externa (AOE) in pediatric, adult, and elderly patients.
Citing IQVIA data, the company noted that the estimated market size for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3 per cent/0.1 per cent, is valued at $110 million USD over 12 months ending in June 2026.
With this approval, Alembic has accumulated a total of 246 ANDA approvals from the U.S. health regulator, of which 226 are final and 20 are preliminary.