Pharma Firm ISO OTC Switch Partner; NDA Experience, Resources Needed
This article was originally published in The Pink Sheet
Success in OTC switches can hinge on finding the right partner, say switch consultants during a CHPA webinar. Due diligence in negotiations can help determine if a potential partner is the right fit for the time- and labor-intensive processes.
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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 grants Glaxo market exclusivity for OTC as the first OTC fluticasone product, but with a label carve-out that limits exclusivity to the indication of “OTC use for temporary relief of ocular symptoms due to hay fever or other upper respiratory allergies.”