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Alembic Pharma receives USFDA approval for generic ear infection drug
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 Sus…
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