Complete Response Letters
Seikagaku Corporation: BLA 761393
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Mar 11, 2025
We have completed our review of this amended application and have determined that we cannot approve this application in its present form.
CRL_BLA761393_20250311:p1:s131. Following pre-license inspection of isted in this application, conveyed leficiencies to the representative of the facility.
CRL_BLA761393_20250311:p1:s16We intend to convey our comments on your proposed package insert following this action.
CRL_BLA761393_20250311:p1:s36(8) Provide English translations of current approved foreign labeling not previously submitted.
CRL_BLA761393_20250311:p2:s3More Complete Response Letters
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