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US FDA denies approval to Mallinckrodt for Terlipressin to treat Hepatorenal Syndrome Type 1
September 16, 2020The Complete Response Letter stated that, based on the available data, the agency cannot approve the terlipressin NDA in its current form and requires more information to support a positive risk-benefit profile for terlipressin for patients with HRS-1. -
US committee backs terlipressin approval for HRS-1
July 17, 2020A US FDA advisory committee has voted in favour of approving Dublin, Ireland-based biopharma Mallinckrodt's terlipressin for Hepatorenal Syndrome Type 1 (HRS-1).
Pharma Sources Insight January 2025
