FDA gives Amneal permission for generic Ciprodex

Amneal has obtained the Food and Drug Administration’s clearance for ciprofloxacin and dexamethasone otic suspension, which is the generic of Ciprodex.

This product is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid. 

It is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in Acute Otitis Externa in pediatric patients aged 6 months old and older, as well as in adult and elderly patients due to staphylococcus aureus and pseudomonas aeruginosa.

[Read more: Amneal debuts 2 generics]

“This approval represents the addition of another complex, high value medicine,” said Andy Boyer, executive vice president, chief commercial officer of generics. “It reflects the ongoing shift of our leading affordable medicines portfolio towards complex products and the continued successful diversification of our business.”