FDA Tentative Approval: SIKLOS — Supplemental Application (Medunik)

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Summary

FDA tentatively approved Medunik's supplemental application for Siklos (hydroxyurea), indicating approvable status for a hydroxyurea product intended to treat s…

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Diseases / indications

• Sickle Cell Disease

Drugs mentioned

• SIKLOS (Hydroxyurea)

Snippet

SUPPL TA for SIKLOS (HYDROXYUREA)