Issued to Valeant Pharmaceuticals Ireland. Application reviewed but not approved; deficiencies must be corrected.
Issued
November 20, 2018Application
NDA 505b1 • 210821
Product
TETRACAINE HYDROCHLORIDE
Company
Valeant Pharmaceuticals Ireland
Review center
Other
Stage
Final Decision
Response due
January 1, 2020
Assyro regulatory brief
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Valeant Pharmaceuticals Ireland on November 20, 2018.
NDA 210821 is the application under which FDA issued this complete response letter for TETRACAINE HYDROCHLORIDE to Valeant Pharmaceuticals Ireland. It was reviewed by FDA Other. The letter is dated November 20, 2018.
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.