Complete Response Letters
Acacia Pharma Ltd: Barhemsys
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, May 2, 2019
No complete sentence from this letter is available from the knowledge graph yet.
Complete Response Letter, Oct 5, 2018
Barhemsys (amisulpride) injection, 5 mg/2 mL.
CRL_NDA209510_20181005:p1:s18During a recent inspection of the ow manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility at the close of the inspection.
CRL_NDA209510_20181005:p1:s23We have the following additional comment/recommendation that is not an approvability issue but should be addressed in the Complete Response action:
CRL_NDA209510_20181005:p2:s12The effects of severe renal impairment on amisulpride pharmacokinetics has not been adequately characterized and amisulpride was studied only in a limited number of patients with severe renal impairment in the clinical trials.
CRL_NDA209510_20181005:p2:s13To inform dosing for patients with severe renal impairment and end-stage renal disease, we recommend that you conduct a pharmacokinetic study following a single dose of amisulpride in patients with severe renal impairment and end-stage renal disease (i.e., eGFR < 30 mL/min/1.73 m7), and healthy subjects as a control group.
CRL_NDA209510_20181005:p2:s15More Complete Response Letters
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