Complete Response Letters
Spes Pharmaceuticals Inc.: fosaprepitant
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Oct 19, 2022
Cosmetic Act (FDCA), for fosaprepitant injection, 150 mg/50 mL (3 mg/mL).
CRL_NDA216686_20221019:p1:s123006503102) manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.
CRL_NDA216686_20221019:p1:s17Satisfactory resolution of these deficiencies is required before this application may be approved.
CRL_NDA216686_20221019:p1:s181000513101) manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.
CRL_NDA216686_20221019:p1:s20We note that you are The hanger attached to the Ensure that the hanger planning to use a hanger | infusion container should not attached to the infusion strap to administer the interference with the ability to container does not interfere product, but it is unclear if | read the drug product with the readability of the the hanger label is information on the label.
CRL_NDA216686_20221019:p2:s2More Complete Response Letters
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