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

Notice of violation letter to Novartis from FDA’s Office of Prescription Drug Promotion expresses concern about describing a patient with five-year survival data, a claim that was added to the label the following month.

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...

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