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Home » Mallinckrodt’s Terlipressin Draws Second Complete Response Letter
Mallinckrodt’s Terlipressin Draws Second Complete Response Letter
The FDA has hit Mallinckrodt Pharmaceuticals with a second complete response letter (CRL), denying approval of its new drug application (NDA) for terlipressin for the treatment of adults with hepatorenal syndrome type 1(HRS-1) and calling for more data.