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FDA clears Intellipharmaceutics' generic Keppra XR

  • The FDA approves Intellipharmaceutics' (NASDAQ:IPCI) abbreviated New Drug Application (ANDA) for levetiracetam extended-release tablets in 500 mg and 750 mg strengths for the treatment of partial onset seizures associated with epilepsy. The product is the generic equivalent of UCB's (OTCPK:UCBJF) Keppra XR.
  • According to Symphony Health Solutions, the U.S. market for the 500 mg and 750 mg products is ~$170M. Mylan's (NASDAQ:MYL) generic version was cleared in December 2011.
  • Shares are up 14% premarket but only on turnover of 225.

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Intellipharmaceutics International Inc.