FDA: More data needed to approve terlipressin NDA for hepatorenal syndrome type 1

Although the FDA accepted a new drug application for terlipressin to treat hepatorenal syndrome type 1, the agency has issued a complete response letter to Mallinckrodt plc stating that more data are required before the NDA can be approved.More specifically, according to a company press release, the complete response letter indicated the FDA seeks more information regarding a positive risk-benefit profile of the drug. Therefore, the FDA will not approve the NDA in its “current form.”The release further noted that terlipressin is approved in many other countries outside the UnitedRead More

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