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Re: Tuff-Stuff post# 529455

Wednesday, 01/08/2014 4:01:12 PM

Wednesday, January 08, 2014 4:01:12 PM

Post# of 648882
FDA lists four new drugs mentioned in Paragraph IV ANDAs

The FDA is out with a list of four new drug products for which the Office of Generic Drugs has received an ANDA containing a Paragraph IV patent certification, meaning the filer contends that a patent listed in the Orange Book either is invalid or unenforceable or will not be infringed by a proposed generic product.
The newly listed drugs: Teva's (TEVA) Treanda, Bausch & Lomb's (VRX) Bepreve and Prolensa, and Forest Labs' (FRX) Namenda XR.
FDA release with link to full .pdf list


http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm047676.htm

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