Glivec imatinib regulatory update

Novartis withdrew an NDA for imatinib to treat pulmonary arterial hypertension (PAH) after FDA told the company additional data would be needed to support approval. The agency subsequently cancelled the Sept. 14 meeting of the Renal Drugs Advisory Committee, which had been scheduled to discuss the application. Novartis said it is working with FDA to determine what additional data is required for a resubmission. ...