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Description
The agency describes the alert as a way to help stop GLP1 APIs with potential quality concerns from entering the U.S

Teduglutide was approved for chronic therapy of subjects with PN-dependent SBS in the US in December 2012 (67)
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While individuals appear able to tolerate small increases in exercise relative to their normal routine, larger increases in training load are associated with higher heart rate and persistently lower HRV during GLP treatment[5]