Intellipharmaceutics (IPCI) Files ANDA for Lamictal XR with FDA
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Intellipharmaceutics International Inc. (Nasdaq: IPCI) (TSX:I) today announced the U.S. Food and Drug Administration (FDA) has accepted for filing its abbreviated new drug application (ANDA) for a generic version of Lamictal XR (lamotrigine extended-release tablets), an anticonvulsant drug used in the treatment of epilepsy.
According to Wolters Kluwer Health, U.S. sales of Lamictal XR, which was approved by the FDA in June 2009, were approximately US$199 million for the 12 months ending September 2011 – an 84% increase over the comparable period in 2010.
Intellipharmaceutics now has six ANDAs being reviewed by the FDA for approval, with reported sales by others for branded and generic versions of these products being approximately $6.6 billion for the 12 months ended September 2011. The Company develops both ANDA product candidates and new drugs through the New Drug Application (NDA) 505(b)(2) regulatory pathway. No assurance can be given as to whether or when the FDA will approve any Intellipharmaceutics application.
According to Wolters Kluwer Health, U.S. sales of Lamictal XR, which was approved by the FDA in June 2009, were approximately US$199 million for the 12 months ending September 2011 – an 84% increase over the comparable period in 2010.
Intellipharmaceutics now has six ANDAs being reviewed by the FDA for approval, with reported sales by others for branded and generic versions of these products being approximately $6.6 billion for the 12 months ended September 2011. The Company develops both ANDA product candidates and new drugs through the New Drug Application (NDA) 505(b)(2) regulatory pathway. No assurance can be given as to whether or when the FDA will approve any Intellipharmaceutics application.
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