FDA approved Mounjaro single-dose vials in 2023, but Lilly never sold them
Mounjaro vials were cleared for sale more than two years ago but are still not available, and only two strengths of the separate Zepbound vials are being sold.
On July 28, 2023, the Food and Drug Administration approved two supplements to the application for Mounjaro (tirzepatide) injection, including one that added a single-dose glass vial version of the type 2 diabetes drug [1]. Those Mounjaro vials were never marketed in the United States and have never been on the agency's drug shortage list [2].
The approval covered supplements S-002 and S-006 to NDA 215866 [1]. S-002 added the single-use glass vial presentation, a manufacturing site for the vials, quality control testing sites, and a secondary packaging site [1]. S-006 was a "Changes Being Effected" supplement that updated sections 4, 5.4, 6.2 and 17 of the Mounjaro prescribing information to reflect new safety information on anaphylaxis and angioedema [1].
The letter was signed on July 28, 2023 by Patrick Archdeacon, M.D., deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research [1].
FDA later described the outcome of that supplement in a December 19, 2024 declaratory order on tirzepatide shortages. "Mounjaro single-dose vial products in the same strengths were approved in a supplement to NDA 215866 in July 2023, but are not currently marketed in the United States and have not been on FDA's drug shortage list," the order states [2]. The strengths are 2.5 mg/0.5 mL, 5 mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL, 12.5 mg/0.5 mL and 15 mg/0.5 mL, the same six strengths as the Mounjaro pens [2]. Lilly has not disclosed why it did not bring the vial presentation to market.
The Mounjaro pens were approved in May 2022 and were added to the shortage list in December 2022 because of high demand [2]. Tirzepatide injection products were first placed on that list on December 15, 2022 [2].
Mounjaro's sister product, Zepbound, has a different record on vials. Zepbound pens were approved in November 2023 and were added to the shortage list in April 2024 [2]. Zepbound single-dose vials were approved in March 2024, but only the 2.5 mg and 5.0 mg strengths are being marketed in the United States, and Zepbound vials have never been on the shortage list [2]. Zepbound is indicated for weight reduction in adults with obesity or with overweight plus at least one weight-related condition; Mounjaro is indicated to improve blood sugar control in adults with type 2 diabetes [2].
Why it matters for patients
The only tirzepatide vials sold in the United States are the Zepbound vials, and only in the 2.5 mg and 5.0 mg strengths [2]. Those are the two lowest strengths of the six approved. A patient who hears that tirzepatide comes in vials should not expect a Mounjaro-branded vial to be an option at the pharmacy.
FDA removed tirzepatide injection products from the shortage list on October 2, 2024, then reevaluated that decision and issued the December 19, 2024 order finding the shortage resolved, based on Lilly data showing supply meeting or exceeding demand [2]. Even so, the agency said it received reports that some patients and pharmacists could not get the approved drugs, and that patients and prescribers may still see intermittent localized supply disruptions as products move from the manufacturer to wholesalers and pharmacies [2]. FDA also noted that substantial compounding of tirzepatide is occurring, and that some patients getting compounded products may seek approved products once compounding is curtailed [2].
What happens next
The December 19, 2024 order set two dates for FDA's enforcement discretion on compounded tirzepatide that depends on shortage-list status: 60 days, until February 18, 2025, for state-licensed pharmacists or physicians compounding under section 503A, and 90 days, until March 19, 2025, for outsourcing facilities under section 503B [2]. FDA said it will keep monitoring supply and demand and may put tirzepatide injection products back on the shortage list if appropriate [2].
Sources
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