Minus one of its GLP-1 cash cows, compounding group sues FDA
WEB19 hours ago · Compounding pharmacies were first allowed to manufacture knock-off versions of diabetes drug Mounjaro when the FDA listed tirzepatide on its shortage page in December of 2022. Then in April of ...
Pharmacies sue FDA over ending Mounjaro, Zepbound shortage
WEB7 hours ago · On Oct. 2, the FDA announced that the nearly two-year-long shortage of tirzepatide, the active ingredient in Mounjaro and Zepbound, had ended. This was after the agency said it had confirmed the ...
FDA clarifies policies for compounders as national GLP-1 supply …
WEB6 days ago · Tirzepatide injection has been in shortage since 2022 due to increased demand. FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can...
Tirzepatide Shortage Resolved? FDA Says Yes, Compounders No
WEB1 day ago · Tirzepatide injection (Zepbound, Mounjaro) is officially off the FDA's drug shortage list, meaning compounders can no longer prepare and dispense the drug. This site is intended for healthcare ...
Mounjaro and Zepbound Are No Longer in Shortage, F.D.A. Says
WEB5 days ago · In announcing the end of the tirzepatide shortage, however, the F.D.A. reiterated that pharmacies could not compound a commercially available drug “regularly, or in inordinate amounts.” Dani ...
FDA warns compounding pharmacies on weight-loss drugs - Axios
WEB5 days ago · Driving the news: The FDA on Wednesday took tirzepatide injections (Mounjaro and Zepbound) off of its official Drug Shortage List and issued a reminder that "compounded drugs must meet conditions to qualify for exemptions" to be sold to the public. Those drugs had been officially designated as in short supply since 2022.
FDA Alert: FDA Clarifies Policies for Compounders as National GLP …
WEBOct 2, 2024 · Tirzepatide injection has been in shortage since 2022 due to increased demand. FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand.
News Release - Eli Lilly and Company
WEBJun 20, 2024 · Lilly will continue to pursue legal remedies against those who falsely claim their products are Mounjaro ®, Zepbound ®, or “FDA-approved” tirzepatide, including certain med-spas, wellness centers, online retailers, and compounding pharmacies.
Lilly Update on Mounjaro® and Zepbound® (tirzepatide) Compounding …
WEBMay 14, 2024 · Lilly has discovered products claiming to be compounded tirzepatide medicines that contain bacteria, high impurity levels, different chemical structures, and different colors than Mounjaro ® or Zepbound ®. In at least one instance, the product was nothing more than sugar alcohol.
FDA’s Removal of Tirzepatide from the Drug Shortage List Sparks …
WEB1 day ago · This case is likely to have significant implications for outsourcing facilities and compounding pharmacies alike, especially those relying on tirzepatide’s previous shortage designation to justify compounding. Tirzepatide, the key ingredient in Eli Lilly’s Mounjaro, had been listed on the FDA’s drug shortage list, allowing 503B facilities ...
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