Complete Response Letters
Valeant Pharmaceuticals Ireland: tetracaine hydrochloride
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Nov 20, 2018
Valeant Pharmaceuticals Ireland c/o Paragon BioTeck Inc.
CRL_NDA210821_20181120:p1:s9Cosmetic Act for tetracaine hydrochloride ophthalmic solution, 0.5%.
CRL_NDA210821_20181120:p1:s16CFR 210 and 211. During a recent inspection of the Bausch & Lomb Inc. (FEI 1000113778) manufacturing facility for this application, our field investigators conveyed observations to the representative of the facility.
CRL_NDA210821_20181120:p1:s19Compliance with current good manufacturing practice regulations is required of all manufacturing facilities before this application may be approved.
CRL_NDA210821_20181120:p1:s21Please submit a revised package insert, draft carton and container labeling that is consistent with the attached labeling.
CRL_NDA210821_20181120:p1:s27More Complete Response Letters
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