Sanofi’s Nasacort AQ Rx-To-OTC Switch Under FDA Review
This article was originally published in The Tan Sheet
FDA’s Nonprescription Drugs Advisory Committee will meet July 31 to discuss Sanofi’s application to switch the intranasal corticosteroid Nasacort AQ to OTC sale, to be indicated for relief of hay fever symptoms in adults and children.
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The OTC Allegra package branding when launched in March 2011 was limited by FDA until after the product lost market exclusivity, consultant Terri Goldstein says. Loss of market exclusivity opened the door to make Allegra branding “how we wished the package could have looked,” she says.
Rhinocort Aqua could be a first-in-class U.S. switch for the nasal corticosteroids, often cited as a potential class for switches. Pfizer gains right of first refusal for the product’s OTC rights from AstraZeneca.
The firm’s opposition to allowing innovative switches for asthma drugs and oral contraceptives focuses on safety and consumers’ ability to self-select and manage their allergies or reproductive status, but maintains that Plan B One-Step and other emergency contraceptives are appropriate for full OTC status.