FDAnews
www.fdanews.com/articles/62379-united-research-laboratories-mutual-pharmaceutical-company-views-legal-response-from-adams-as-excessive-and-disingenuous-attempt-to-delay-competition

UNITED RESEARCH LABORATORIES/MUTUAL PHARMACEUTICAL COMPANY VIEWS LEGAL RESPONSE FROM ADAMS AS EXCESSIVE AND DISINGENUOUS ATTEMPT TO DELAY COMPETITION

September 8, 2006

United Research Laboratories, Inc. and Mutual Pharmaceutical Company, Inc. announce that Adams Respiratory Therapeutics has requested that Mutual agree to produce thousands of irrelevant documents related to the company's filing of an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) for Mutual's guaifenesin extended-release tablets, 600 mg and 1200 mg, which are the generic equivalent to Adams' Mucinex brand. Adams has suggested that Mutual agree to produce these documents as the condition for according confidential treatment to any of Mutual's documents and information. Mutual believes these tactics are being used for the sole purpose of improperly obtaining an automatic stay of FDA's approval of Mutual's ANDA and delaying Mutual's product launch.
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