Complete Response Letters
Rosemont Pharmaceuticals Holdings, Inc.: valacyclovir
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Mar 5, 2026
The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response.
CRL_NDA220140_20260305:p1:s19The facility's satisfactory responses are dependent on FDA's determination that the facility has come into compliance with CGMP and may require re-inspection of the facility.
CRL_NDA220140_20260305:p1:s20Following resolution of the CGMP inspection, FDA may need to conduct a Preapproval inspection (PAI) of the facility.
CRL_NDA220140_20260305:p1:s23Satisfactory outcomes of both the PAI and the CGMP surveillance inspections will be needed prior to approval of the application.
CRL_NDA220140_20260305:p1:s24(8) Provide English translations of current approved foreign labeling not previously submitted.
CRL_NDA220140_20260305:p2:s6More Complete Response Letters
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