FDA Cites Gleevec For Promoting Unapproved Indications Three Weeks Before Expanding Label

Getting a little ahead of a supplemental approval in its promotional materials for the oncology drug Gleevec (imatinib) helped land Novartis AG a “notice of violation” letter from FDA’s Office of Prescription Drug Promotion.

OPDP singled out three “GISTexchange Case Highlights” that the company had submitted for approval, referring to the drug’s...