Alembic Pharmaceuticals 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 ANDA is therapeutically equivalent to the reference listed drug product (RLD), Ciprodex Otic Suspension, 0.3% / 0.1%, of Sandoz Inc.
Ciprofloxacin and Dexamethasone Otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions: Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes, and Acute Otitis Externa (AOE) in pediatric (age 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 $110 million for twelve months ending June 2026. The company has a cumulative total of 246 ANDA approvals (226 final approvals and 20 tentative approvals) from USFDA.
Alembic Pharmaceuticals is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.
