FDA Faults Teva’s Promotion Of Clozapine Tablets in ‘Untitled’ Letter

In a letter posed April 22, the Food and Drug Administration told Teva Neuroscience Inc. that an article detailer for clozapine tablets is misleading because it makes unsubstantiated superiority and other claims regarding the drug, omits material facts, and minimizes the drug’s risks.

The agency posted its “untitled” letter to the company’s Kansas City, Mo., office. Clozapine is the generic equivalent of Novartis Pharmaceuticals Corp.'s Clozaril, according to Teva’s website. The drug is indicated for management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatment. Because of the significant risk of agranulocytosis and seizure associated ...