Alembic Pharma gets USFDA nod for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%

Alembic Pharmaceuticals 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 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. Refer label for a detailed indication. 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. Alembic has a cumulative total of 246 ANDA approvals (226 final approvals and 20 tentative approvals) from USFDA. The post Alembic Pharma gets USFDA nod for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1% appeared first on Express Pharma.