Sanofi Sues FDA To Stop Publication Of Nasacort Labeling Before Launch
This article was originally published in The Tan Sheet
Executive Summary
After FDA denied Sanofi three years of market exclusivity for OTC Nasacort, the firm filed suit against the agency not to publish the product’s labeling prior to the launch. If successful, the firm could postpone the launch of generic competition.
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Glaxo says Flonase Allergy Relief (fluticasone propionate 50 mcg spray) is the “first OTC nasal spray indicated for relief of all nasal and eye-related allergy symptoms.” The firm has not learned from FDA whether Flonase Allergy Relief will launch with market exclusivity.
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Glaxo says Flonase Allergy Relief (fluticasone propionate 50 mcg spray) is the “first OTC nasal spray indicated for relief of all nasal and eye-related allergy symptoms.” The firm has not learned from FDA whether Flonase Allergy Relief will launch with market exclusivity.
Sanofi Lawsuit Delays OTC Nasacort Generic Competition
Sanofi says with Nasacort Allergy 24HR available at retailers nationwide and online, the firm withdrew its litigation against FDA, which appears to have slowed development of private-label equivalents.
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