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

 
• By Martin Berman-Gorvine

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 “

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More from North America

HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 
• By Derrick Gingery

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Most Favored Nation Policy ‘Lazy, Misguided,’ But US Price Reforms Politically ‘Inevitable’

 
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