Complete Response Letters
Antares Pharma, Inc.: hydrocortisone sodium phosphate
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Aug 16, 2024
No complete sentence from this letter is available from the knowledge graph yet.
Complete Response Letter, Oct 20, 2017
Please refer to your New Drug Application (NDA) dated and received December 20, 2016, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), for testosterone enanthate subcutaneous injection.
CRL_NDA209863_20171020:p1:s151. Based on the findings in Studies QST13-003 and QST15-005, we are concerned that your testosterone enanthate product could cause a clinically meaningful increase in blood pressure.
CRL_NDA209863_20171020:p1:s19One approach is to include prespecified, periodic, validated psychiatric evaluations to monitor and assess for the occurrence of depression and suicidality in the ABPM study mentioned above.
CRL_NDA209863_20171020:p1:s34Urologic Drugs Advisory Committee to obtain expert advice on whether the demonstrated benefit of treatment with testosterone enanthate injection outweighs the potential of increased cardiovascular and suicidality risks with its use in the real world setting.
CRL_NDA209863_20171020:p1:s37Submit draft carton and container labeling based on our proposed revisions dated May 18, 2017.
CRL_NDA209863_20171020:p2:s22More Complete Response Letters
Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.