Interneuron regulatory update

IPIC received a non-approvable letter from the FDA regarding dexfenfluramine, IPIC's obesity drug. The principal issues raised in the letter concern the risk of developing pulmonary hypertension and the potential for neurotoxicity, IPIC said.

The Lexington, Mass., company said it plans to submit data addressing those issues within several weeks. IPIC, which submitted its NDA in May 1993, declined to elaborate on the issues raised by the FDA or to describe the data it plans to add to its NDA. ...