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We continue to hear from pharmacies that the FDA-approved tirzepatide drugs are not attainable from wholesalers in quantities needed to meet demand by patients transitioning from compounded to commercial versions of the drug. In the FDAs 12-page letter lifting the tirzepatide shortage, the agency asserted its authority to make its own decisions about shortages, responding to the compounder plaintiffs allegations that its process for resolving the shortage was a violation of the Administrative Procedure Act
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While no drugs are FDA-approved specifically for PCOS, medications like Metformin and Thiazolidinediones (Pioglitazone, Rosiglitazone), originally approved for Type 2 diabetes, are widely used off-label to improve insulin sensitivity, regulate menstrual cycles, and support fertility
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