FDA approves Nasonex for over-the-counter use
Perrigo announced that the FDA has approved mometasone furoate monohydrate, an intranasal corticosteroid nasal spray designed to treat and prevent hay fever and allergy symptoms, for over-the-counter use.
The company said it expects to begin offering mometasone furoate monohydrate (Nasonex 24HR Allergy) as an OTC product later this year.
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Perrigo is using Nasonex, which is a registered trademark of Organon LLC, under license.
“This first Rx-to-OTC switch for Nasonex represents our continued focus on providing quality, affordable self-care products that consumers known and trust,” Jim E. Dillard III, Perrigo executive vice president and president of consumer self-care Americas, said in a press release.
“It also epitomizes the strength of our internal innovation, R&D and regulatory capabilities. Successfully bringing Rx-to-OTC switches to market expands offerings available to consumers, enhances offerings for our retail partners and continues to differentiate Perrigo in the marketplace,” Dillard said.