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Understanding the PDUFA Date System When drug companies submit a Biologics License Application (BLA) which is what Eli Lilly will file for retatrutide, since it's regulated as a biologic rather than a small-molecule drug the FDA assigns a PDUFA date : Prescription Drug User Fee Act date
Low blood glucose (sugar), or hypoglycemia, is rare with Ozempic and other GLP-1s when taken alone
At the 6-month review, GLP-1 receptor agonists only continue if a response is observed
Review any medication changes that coincided with apparent efficacy loss
GI side effects improve
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