Alembic Pharmaceuticals Ltd on Monday said it has received the final approval from the US Food and Drug Administration (USFDA) for its generic Ciprofloxacin and Dexamethasone Otic Suspension USP.
The product is indicated for the treatment of certain ear infections in paediatric patients aged six months and older, as well as adults and elderly patients.
The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD), Ciprodex Otic Suspension, 0.3 per cent/0.1 per cent, of Sandoz Inc, the company said in a statement.
The drug is indicated for the treatment of infections caused by susceptible isolates of designated microorganisms in specific conditions, including Acute Otitis Media (AOM) in pediatric patients aged 6 months and older with tympanostomy tubes, and Acute Otitis Externa (AOE) in pediatric (6 months and older), adult, and elderly patients, it said.
Citing IQVIA data, the company said Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3 per cent/0.1 per cent, had an estimated market size of USD 110 million for the 12 months ending June 2026.
With this clearance, Alembic has accumulated a total of 246 ANDA approvals from the US health regulator, comprising 226 final approvals and 20 tentative approvals, it added.
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