Another Black Cloud Douses Valeant's Sunlight
Valeant Pharmaceuticals International Inc. started the week out strong – winning approval to market an oral formulation of Relistor and gaining an FDA advisory committee's backing to sell the company's plaque psoriasis drug brodalumab. But that winning streak came to an abrupt halt with the agency's rejection of the firm's eye treatment latanoprostene bunod.
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FDA notified the company the US review goal date for the psoriasis pill has been extended three months from Nov. 16 to Feb. 16.
While an FDA advisory committee unanimously supported approval of the plaque psoriasis drug brodalumab, several recommended a black box warning on suicide risk that could limit sales of the drug.
FDA approval of the first oral form of Valeant’s mu-opioid receptor antagonist Relistor will pit the franchise against Movantik for the treatment of patients with opioid-induced constipation with non-cancer pain.