Complete Response Letters
Clearside Biomedical, Inc.: XIPERE
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Oct 18, 2019
505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), for XIPERE (triamcinolone acetonide ophthalmic suspension) for suprachoroidal injection.
CRL_NDA211950_20191018:p1:s14Satisfactory resolution of the observations is required before this NDA may be approved or alternative manufacturing facilities which are in compliance with cGMPs must be included in the application.
CRL_NDA211950_20191018:p1:s212. There is insufficient information about the drug product to determine whether the product is safe for use under the conditions prescribed, recommended or suggested in the proposed labeling.
CRL_NDA211950_20191018:p1:s22The final rule became effective on December 5, 2016.
CRL_NDA211950_20191018:p1:s35December 5, 2016, clearly referencing each amendment by submission date, and either:
CRL_NDA211950_20191018:p1:s44The cover letter for your Complete Response and all future amendments to your unapproved 505(b)(2) application should continue to address the requirements under 21 CFR 314.60(f).
CRL_NDA211950_20191018:p2:s05. The drug product is an ophthalmic suspension.
CRL_NDA211950_20191018:p2:s7'ake before the application may be approved.
CRL_NDA211950_20191018:p2:s41More Complete Response Letters
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