Blog: Sanofi sues FDA to delay publication of OTC Nasacort labeling

WASHINGTON — Sanofi-Aventis has sued the Food and Drug Administration to keep its labeling for OTC Nasacort confidential in an effort to delay store brand competition until after the launch, according to an entry in the FDA Law Blog, the official blog of Hyman, Phelps & McNamara, published Thursday. 

Sanofi was not granted three years of product exclusivity with the Nasacort switch. By not releasing official labeling before the OTC debut, generic brand manufacturers will not have the advanced knowledge they need to introduce a private label version of Nasacort at the time of launch. 

The FDA is expected to make Nasacort labeling available on its site on Nov. 12. 

 

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