Complete Response Letters
Eagle Pharmaceuticals, Inc.: Fulvestrant
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Apr 13, 2026
We acknowledge receipt of your major amendment dated November 18, 2025, which extended the goal date by three months.
CRL_NDA220045_20260413:p1:s12The facility should provide satisfactory responses to these deficiencies to our office indicated on the FDA Form 483 prior to your complete response.
CRL_NDA220045_20260413:p1:s18More Complete Response Letters
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