- 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.
Flamel gets a CRL
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