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Home » FDA Slaps Catalyst’s NDA With Refusal to File Letter
FDA Slaps Catalyst’s NDA With Refusal to File Letter
The FDA has rebuffed Catalyst Pharmaceuticals, firing off a refusal to file letter for the rare disease drugmaker’s NDA for Firdapse.
According to Catalyst, the letter neither commented on the submitted clinical data, nor made a judgment on the safety or efficacy of the candidate, which is being developed to treat Lambert Eaton myasthenic syndrome and congenital myasthenic syndromes.
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