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.
Go deeper with GlobalData
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.
See Also:
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalData
