Valeant's Siliq Clears FDA Panel But Faces Prospect Of Post-Marketing Registry
Agency's advisors were divided on whether Valeant's proposal for voluntary registry would suffice or whether mandatory program under REMS was needed to better assess risk of suicide and suicidal behavior with psoriasis drug.
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Keeping Track: US FDA Approves Siliq, Accepts Mylan/Biocon Pegfilgrastim Biosimilar
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US FDA Approval Of Valeant’s Siliq Comes With REMS, Boxed Warning
Measures are aimed at mitigating risk of suicidal ideation and behavior with the psoriasis drug, but company will not have to conduct a postmarketing registry to evaluate this risk.
Where’s The Suffix? Valeant’s Siliq Approved Without Four-Letter Identifier
Psoriasis treatment brodalumab is first novel biologic approved since US FDA released its final guidance on nonproprietary naming for new biologics and biosimilars; agency says it didn't want to delay the approval by taking more time to develop a suffix.