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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
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