After almost two years, federal regulators introduced the scarcity of the lively ingredient in Mounjaro and Zepbound has been resolved.
Tirzepatide, the lively ingredient within the diabetes and weight problems medicines Mounjaro and Zepbound, was declared in scarcity in December 2022. The scarcity has been attributed to elevated demand as curiosity in GLP-1 medicines has soared.
The Meals and Drug Administration (FDA) confirmed in an announcement Wednesday that the scarcity is now thought of to be resolved.
“FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand,” the company mentioned in an announcement. “Patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.”
The drug’s scarcity standing has allowed for compounded variations, which drug producers have derisively known as “copycat” variations, to be offered by clinics and telehealth platforms.
These compounded variations have proliferated on-line, promising customers the identical lively ingredient for a fraction of the associated fee. Whereas compounding pharmacies are FDA-regulated, the merchandise they promote are usually not and weight problems specialists have raised considerations concerning the widespread availability of those medication.
In its announcement of the scarcity ending, the FDA provided some clarification relating to compounded GLP-1 medication.
“Compounded drugs are not approved by FDA. FDA-approved drugs go through FDA’s rigorous review for safety, effectiveness, and quality as part of the premarket approval process,” mentioned the company.
There are two varieties of compounding pharmacies: 503A and 503B. Telehealth platforms use 503B compounding pharmacies to supply their compounded GLP-1s.
The FDA reiterated Wednesday that underneath the Federal Meals, Drug and Beauty Act, compounded medication offered by 503B pharmacies “may not be identical or nearly identical to an FDA-approved drug unless the approved drug is on FDA’s drug shortage list.”
With tirzepatide now not in scarcity, the flexibility of on-line corporations to promote their compounded variations now falls underneath query. One such platform, Eden, continues to be promoting its compounded tirzepatide as of Wednesday night. The Hill has reached out to the corporate for remark.
Eli Lilly, the producer of tirzepatide, has sued medspas and pharmacies promoting compounded variations. The corporate has beforehand mentioned it was “deeply concerned about the proliferation of counterfeit, fake, and other unapproved and untested incretin knockoffs.”
The Hill has reached out to Eli Lilly for remark.
