Earlier this week, sanofi-aventis U.S., LLC (“Sanofi”) filed a Complaint in the U.S. District Court for the District of Columbia against FDA in what appears to be a first-of-its-kind lawsuit. Sanofi alleges that FDA’s decision to make public a copy of the labeling approved on October 11, 2013 under NDA No. 020468 for the Over-the-Counter (“OTC”) use of Nasacort Allergy 24 HR (“OTC NASACORT”) for the temporary relief of symptoms of hay fever or other respiratory allergies (nasal congestion, runny nose, sneezing, and itchy nose) in adults and children ages 2 years and older violates the Administrative Procedure Act (“APA”).
Despite having approved a prior approval supplement (S-035) under NDA No. 020468 for the prescription-to-OTC use of NASACORT nearly a month ago, despite having received four Freedom of Information Act (“FOIA”) requests to release the labeling, and despite FDA policy, the Agency has failed to post on the CDER Internet Web Page (at Drugs@FDA) a copy of the approved labeling text.
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