Complete Response Letters
Novartis Pharmaceuticals Corporation: inclisiran
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Dec 18, 2020
These objectionable conditions will be conveyed to the representative of the facility within 10 business days of this Complete Response Letter.
CRL_NDA214012_20201218:p1:s17Satisfactory resolution of these objectionable conditions is required (e.g., preapproval inspection and/or adequate facility responses addressing these conditions) before this application may be approved.
CRL_NDA214012_20201218:p1:s18If it is determined that an inspection is needed to approve your application, please note that FDA continues to monitor the public health situation as well as travel restrictions.
CRL_NDA214012_20201218:p1:s19More Complete Response Letters
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