Amneal Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved an 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.

With the FDA approval, the New Jersey-based pharma company will develop an affordable, complex, and high-value product that reflects the “diversification of [the] business” and its evolving portfolio, said Amneal’s generics executive vice-president Andy Boyer in the 25 March press release.

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

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.

Novartis reported a 62% rise in net income in 2023, increasing from $6.04bn to $8.6bn on constant currencies.

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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