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Stannsoporfin Approval Status

FDA Approved: No
Generic name: stannsoporfin
Company: Mallinckrodt Inc.
Treatment for: Hyperbilirubinemia

Stannsoporfin is a heme oxygenase inhibitor in development for the treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice.

Development Status and FDA Approval Process for stannsoporfin

DateArticle
Aug 22, 2018Mallinckrodt Confirms Receipt of Stannsoporfin Complete Response Letter
May  3, 2018Mallinckrodt Reports on FDA Joint Advisory Committee Meeting for Stannsoporfin for the Treatment of Newborns at Risk of Developing Severe Jaundice
Feb 23, 2018Mallinckrodt Receives FDA Acceptance of Stannsoporfin New Drug Application Filing
Jan  4, 2018Mallinckrodt Completes Stannsoporfin New Drug Application Filing

Further information

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