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Avanir Pharmaceuticals Announces Paragraph IV ANDA Filing for NUEDEXTA

Fri, 07/01/2011 - 5:35am
Bio-Medicine.Org

ALISO VIEJO, Calif., July 1, 2011 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) website indicates that an Abbreviated New Drug Application (ANDA) for a generic version of NUEDEXTA® (dextromethorphan hydrobromide and quinidine sulfate) capsules was submitted on March 7, 2011. The company received Paragraph IV certification notices on June 30, 2011.

Avanir intends to vigorously enforce its intellectual property rights relating to NUEDEXTA, which is protected by several patents covering the method of use of the product and its formulation. All of the currently issued patents are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Under the FDA's rules and regulations, if Avanir initiates a patent infringement suit to defend the patents identified in any Paragraph IV notice it receives within 45 days after its receipt of such notice, the FDA is prevented from approving the ANDA until the earlier of: (1) 30 months; (2) the expiration of the patents at issue; or (3) a decision in the infringement case that all of such patents are not infringed or invalid.

About Avanir Pharmaceuticals, Inc.

Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.

About NUEDEXTA

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