FDA Says Compounded Tirzepatide Must Exit the Market

Compounders only have 2 to 3 months left to copy injectable

https://www.medpagetoday.com/endocrinology/obesity/113478

The shortage of the diabetes and obesity injectable tirzepatide (Mounjaro, Zepbound) has been resolved, the FDA announced

As a result, compounders will have a grace period of 60 to 90 days to wrap up production and distribution of the combination GIP/GLP-1 receptor agonist during which the FDA won’t take legal action against them, “to avoid unnecessary disruption to patient treatment and to help facilitate an orderly transition,” the agency noted in a letter to maker Eli Lilly

Compounders are only allowed to make copies of a drug when it’s on the FDA shortage list, meaning the demand or projected demand of that drug exceeds the U.S. supply.

First added to the shortage list nearly 2 years ago, the agency initially determined that the tirzepatide shortage was resolved on Oct. 2, prompting it to be removed from the drug shortage list.

But just 5 days later, the FDA was sued by compounders, and as part of a court order, the agency had to reevaluate its decision to remove tirzepatide from the shortage list — a decision that has now been confirmed.

As part of its reevaluation, the agency concluded that the supply is “currently meeting or exceeding demand for these drug products, and that Lilly has developed reserves that it now holds in its finished product inventory, plus significant units of semi-finished product, and has scheduled substantial additional production over the coming months, such that supply will meet or exceed projected demand.”

But even after a shortage is considered resolved, patients and prescribers could still face intermittent localized supply disruptions as products move through the supply chain from the manufacturer and distributors to local pharmacies, the agency noted in their letter.

Furthermore, the 60- to 90-day grace period doesn’t preclude the FDA from taking action for other violations, including in cases of substandard quality or safety concerns.

Approved in 2022 for type 2 diabetes and in 2023 for chronic weight management along with diet and exercise, tirzepatide is the only once-weekly dual GIP/GLP-1 receptor agonist on the market and is arguably the most effective weight-loss injectable

As of today, three other GLP-1 receptor agonists remain on the FDA’s shortage list: semaglutide (Ozempic, Wegovy), dulaglutide (Trulicity), and liraglutide (Victoza, Saxenda). All have been reported as “available” by their respective manufacturers, but the FDA hasn’t formally declared their shortages to be resolved yet.

The agency said it will continue to monitor supply and demand for these products, including tirzepatide.

Filed under: General Problems