Issued to Laboratorios Farmaceuticos Rovi, S.A.. Application reviewed but not approved; deficiencies must be corrected.
Issued
September 24, 2021Application
NDA 505b1 • 214835
Product
RISVAN
Company
Laboratorios Farmaceuticos Rovi, S.A.
Review center
Other
Stage
Final Decision
Response due
November 13, 2026
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Device constituent and human factors, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Laboratorios Farmaceuticos Rovi, S.A. on September 24, 2021.
NDA 214835 is the application under which FDA issued this complete response letter for RISVAN to Laboratorios Farmaceuticos Rovi, S.A.. It was reviewed by FDA Other. The letter is dated September 24, 2021.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.