The US Food and Drug Administration’s objections to two television ads for Eli Lilly and Company’s migraine drug Emgality (galcanezumab-gnlm) were so quickly quelled that the agency posted its untitled letter and a close-out letter at the same time. It is the first time the Office of Prescription Drug Promotion has posted these letters simultaneously.
On 13 December, OPDP sent an untitled letter to Lilly stating that two of its direct-to-consumer broadcast TV ads failed to include any risk information and omitted major side effects and contraindications associated with Emgality
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