1. Pink Sheet

Sanofi Sues FDA To Stop Publication Of Nasacort Labeling Before Launch

 
• By Elizabeth Crawford

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.

Sanofi is trying to force a period of exclusivity for its recently approved OTC switch Nasacort Allergy 24HR by suing FDA to block disclosure of labeling prior to the product’s launch in 2014.

In what attorneys say seems to be a first-of-its-kind complaint filed Nov. 6 in the U.S

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