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Flamel gets a CRL

Apr. 29, 2014 2:13 PM ETAvadel Pharmaceuticals plc (AVDL) StockBy: Douglas W. House, SA News Editor
  • The FDA sends Flamel Technologies (FLML -15%) a complete response letter (CRL) regarding its second NDA application from the Eclat portfolio. During an on-site inspection of a ingredient supplier's operations, some facility deficiencies were noted. These must be rectified before the agency will approve the application.
  • The company received the CRL on the PDUFA date. A new one will be established when the firm addresses the issues and resubmits its application.

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