Aug 25 2010
Warner Chilcott plc (Nasdaq: WCRX) today announced that it has received the Food and Drug Administration's ("FDA's") response to a citizen petition it had filed regarding its ASACOL and ASACOL HD products. In its petition, Warner Chilcott requested that the FDA (1) issue bioequivalence guidance for mesalamine delayed-release tablets, (2) not approve any abbreviated new drug applications ("ANDAs") referencing ASACOL and/or ASACOL HD unless the proposed generic product is shown to be bioequivalent based on appropriate data from a clinical efficacy endpoint study, comparative pharmacokinetic testing and rigorous in vitro dissolution testing and (3) deny any waiver of bioequivalence testing for either ASACOL or ASACOL HD based on a showing of bioequivalence in the other strength. In its joint-response to the citizen petitions of the Company and another petitioner, the FDA has granted in part and denied in part various aspects of the citizen petitions. The impact of the FDA's response will depend upon the particular facts of any ANDA filed referencing ASACOL and/or ASACOL HD.
A copy of the FDA's response letter is available in the Investor Relations section of the Company's website at www.wcrx.com. In addition, the Company's citizen petition and related information and the FDA's response letter are, or will be made available, on the www.regulations.gov website.
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