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:
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Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes, and
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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.