Rhinocort Switch Makes Three In OTC Intranasal Corticosteroid Market

CDER’s approval of McNeil’s supplemental NDA for the budesonide spray came without an advisory committee opinion, a step the agency required for the first switch in the category, Glaxo’s Flonase Allergy Relief. OTC Rhinocort is indicated for temporary relief of symptoms of hay fever or other upper respiratory allergies in adults and children ages 6 and up, with separate directions for use by children ages 6 to 12.

FDA’s approval of Rhinocort Allergy Spray marketed OTC by McNeil Consumer Healthcareincreases to three the number of competitors in the next great switch category, intranasal corticosteroids.

The Center for Drug Evaluation and Research’s approval of the Johnson & Johnson subsidiary’s supplemental new drug application for the budesonide product (32 mcg per spray) came without an advisory committee opinion, a step the agency required for the first switch in the category, Sanofi’s Nasacort 24 HR (triamcinolone

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