The agency’s accusations focus on Bristol Myers’ claims on its website about the drugs’ efficacy and effect on survival, according to a letter dated Aug. 1 and sent to the company from the FDA’s Office of Prescription Drug Promotion.
Krazati is FDA approved for the treatment of locally advanced or metastatic non-small cell lung cancer.
The FDA received multiple complaints about the false or misleading claims through its Bad Ad Program, the agency wrote in the letter. The agency said in its letter that Bristol Meyers has 15 days from receipt to respond to the concerns.
Read the FDA’s letter here.
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