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Amneal gains FDA greenlight to develop Ciprodex generic for ear infections

2024-03-26

上市批准快速通道合格传染病产品

Amneal aims to develop an affordable, complex, high-value product for bacterial ear infections. Credits: goodlux/Shutterstock.com.

Amneal Pharmaceuticals announced that the US Food and Drug Administratbacterial ear infectionsn abbreviated new drug application (ANDA) for its ciprofloxacin and dexamethasone otic suspension, a generic drug of Novartis’ Ciprodex (ciprofloxacin/dexamethasone), for the treatment of ear infections.

Amneal Pharmaceuticals the New Jersey-based pFood and Drug Administration (FDA)rdable, complex, and high-value product that reflects the “diversciprofloxacin[the]dexamethasoned its evolving portfolio, said AmneaNovartisriCiprodexticiprofloxacinddexamethasoner in the 25 March press ear infections

An approvFDAANDA allows a sponsor to manufacture and market a safe and effective generic product at a lower cost than the brand-name product it references.Amneal

Ciprodex is designed to prevent bacterial DNA replication and the growth of new bacteria via the antibiotic ciprofloxacin. It suppresses inflammation by inhibiting the synthesis of cytokines associated with inflammation. As per its label, the drug is indicated to treat infections caused by susceptible isolates of the designated microorganisms in acute otitis media (AOM) and acute otitis externa (AOE) in patients aged six months and older.

Ciprodex reported a 62% rise in net income in 2023, increasing from $6.04bn to $8.6bn on constant currenciesciprofloxacin inflammation inflammation infections acute otitis media (AOM)acute otitis externa (AOE)

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Amneal is among several companies marketing generics of Novartis’ combination ear drop medication. India-based Dr Reddy’s launched its Ciprodex generic after receiving FDA approval in August 2020.

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