Santarus (SNTS) Files Citizen Petition to the FDA Over Budesonide XR Tabs

February 1, 2013 4:14 PM EST
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On February 1, 2013, Santarus, Inc. (Nasdaq: SNTS) submitted a Citizen Petition to the U.S. Food and Drug Administration (the “FDA”) requesting that the FDA (1) develop and publish an individual bioequivalence recommendation for budesonide extended release tablets and (2) refrain from approving any abbreviated new drug application that identifies Uceris™ (budesonide) extended release tablets as the reference listed drug unless the generic product is shown to be bioequivalent based on appropriate data from a clinical efficacy endpoint study, comparative pharmacokinetic testing, in vitro dissolution testing, and pharmacoscintigraphy studies.

Citizen petitions are filed to ask that the FDA take, or refrain from taking, a particular action. Any person may file a citizen petition, and any person may comment on a petition that has been filed. Petitions are governed by and must comply with FDA regulations, specifically 21 C.F.R. § 10.30, as well as the Federal Food, Drug, and Cosmetic Act, specifically 21 U.S.C. § 355(q) when applicable.

Santarus cannot predict when or if the FDA will respond to, or otherwise take any action with respect to, the Citizen Petition. A copy of the Citizen Petition is available in the Investor Relations section of Santarus’ website at under the heading “Featured Reports.”

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