Complete Response Letters
Fennec Pharmaceuticals, Inc.: PEDMARK
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Nov 26, 2021
There is an increased incidence of Grade 3 - 4 hypophosphatemia (in SIOPEL6 and ACCL0431) and Grade 3 - 4 hyponatremia (in ACCL0431) in patients receiving sodium thiosulfate injection with cisplatin compared to patients receiving cisplatin alone.
CRL_NDA212937_20211126:p1:s30Provide an analysis of hypophosphatemia and hyponatremia in your safety database to support your conclusion that these treatment-emergent adverse events are not related to sodium thiosulfate injection to inform our decision-making regarding whether hypophosphatemia and hyponatremia should be described in Section 5 (Warnings and Precautions) of product labeling for sodium thiosulfate injection.
CRL_NDA212937_20211126:p1:s32Complete Response Letter, Aug 10, 2020
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