The US Food and Drug Administration (FDA) has announced that tirzepatide injection products, including Eli Lilly’s weight loss drug Zepbound, are no longer in short supply. After a two-year shortage, the FDA has confirmed that these products are now fully available again.
Since the shortage began, specialty and compounding pharmacies have been selling off-brand versions of tirzepatide at lower costs, often between $250 to $350 per month. However, this is changing as Eli Lilly’s spokesperson stated that the FDA’s decision reflects the company’s efforts to expand its manufacturing capacity and bring these medicines to those who need them.
The FDA has cited concerns over overdoses related to incorrect dosing of off-brand drugs, which are not FDA-approved and may have different formulas than name brands. Patients giving themselves the wrong dose or healthcare professionals miscalculating doses are among those affected by these errors.
Eli Lilly and other pharmaceutical companies have been cracking down on counterfeit versions of their weight loss drugs, suing medical spas, compounding pharmacies, and clinics that sell unapproved versions of these medications. The FDA has also removed tirzepatide from the list of ongoing shortages, but plans to reevaluate its decision in the coming period.
As a result, patients can now access the FDA-approved version of Zepbound at a potentially lower cost through a new partnership between Ro, a telehealth company, and Eli Lilly. The partnership aims to sidestep supply-chain issues with prefilled pens by selling a half-price version of the medication in vials.
Source: https://people.com/zepbound-no-longer-in-shortage-fda-compounding-pharmacies-what-it-means-8766705