New Delhi, Oct 19: Alembic Pharmaceuticals Limited today announced that it has received final approval from the US Food & Drug Administration  for its Abbreviated New Drug Application for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%.

The approved ANDA is therapeutically equivalent to the reference listed drug product, 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:

i) Acute Otitis Media  in pediatric patients with tympanostomy tubes, and ii) Acute Otitis Externa in pediatric , 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 US$110 million for twelve months ending June 2026.

Alembic has a cumulative total of 246 ANDA approvals from USFDA.