Sucampo gets CRL

The FDA sends Sucampo Pharmaceuticals (SCMP -0.1%) a complete response letter (CRL) to its prior approval supplement (PAS) after its review of the revised Drug Master File (DMF) of R-Tech Ueno, Ltd. R-Tech revised its DMF when it relocated its manufacturing facility for Rescula (unoprostone isopropyl ophthalmic solution) to Nitto Medic Co. The FDA issues its CRL because previously cited deficiencies have not been corrected. Sucampo plans to resubmit its PAS in 2H 2014. It has an adequate supply of Rescula to service the U.S. market into Q1 2015.

Comments (1)
  • carsons7
    , contributor
    Comments (139) | Send Message
    There has been zero sales of this product for the last 12 months, so this is no biggie.. (hope you caught that tidbit). On the other hand, this is the THIRD CRL in the last 6 months!
    29 May 2014, 08:59 PM Reply Like
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