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.