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.
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The troubled firm has pushed back its greatest debt burden until 2020, but new products are unlikely to fill sales gap. Valeant says its GI unit is showing positive signs and that a restructuring of the derm commercial unit is nearing completion.
Valeant is touting Siliq to lead new product growth, but the drug's significant safety concerns in a competitive psoriasis market likely will offset efficacy advantages it could offer.
Novel approvals by US FDA in 2017 could easily surpass the 28 agents approved by the agency's drug and biologics centers in 2016. The big question is whether last year's spike in complete response letters was an anomaly or the start of a trend.