By: IPP Bureau
Last updated : October 17, 2026 8:12 pm
The approved ANDA is therapeutically equivalent to the reference listed drug, Ciprodex Otic Suspension (0.3%/0.1%) by Sandoz
Alembic Pharmaceuticals Limited today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%.
The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug (RLD), Ciprodex Otic Suspension (0.3%/0.1%) by Sandoz Inc.. This Ciprofloxacin and Dexamethasone Otic Suspension is indicated for treating ear infections caused by susceptible bacterial strains in the following conditions:
* Acute Otitis Media (AOM): For pediatric patients aged 6 months and older who have tympanostomy tubes.
* Acute Otitis Externa (AOE): For pediatric (6 months and older), adult, and elderly patients.According to IQVIA, the estimated market size for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%, was US$110 million for twelve months ending June 2026.
Alembic has a cumulative total of 246 ANDA approvals (226 final approvals and 20 tentative approvals) from USFDA.