Eli Lilly's blockbuster weight-loss drug is no longer in shortage in the United States, the US Food and Drug Administration's website showed on Wednesday.
The shortage of all doses of the drug, tirzepatide, sold as Mounjaro for diabetes and Zepbound for weight management has been resolved, the FDA said.
As products move through the supply chain, patients and prescribers may still experience occasional local shortages, the agency said.
Lilly did not immediately respond to a Reuters request for comment.
Mounjaro has been on the FDA's shortage list since late 2022, while Zepbound was added to the list in April this year.
The drugmaker had begun selling vials of the lowest starter dose of Zepbound in the United States through its direct-to-consumer website to help increase its availability in the marketplace.
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Surging demand for Mounjaro and Zepbound has led Lilly to invest billions of dollars in boosting their production.
Danish drugmaker Novo Nordisk, which makes rival drugs Ozempic and Wegovy, is also working to ramp up supply to meet unprecedented demand.
The FDA usually evaluates the market for a drug, and assesses whether all backorders have been filled for the drug before deciding on whether a shortage has been resolved.
The health regulator said it confirmed with Lilly that the current supply and manufacturing capacity could meet the present and projected national demand for the drug.
Originally developed for diabetes, GLP-1 therapies have shown to reduce weight by as much as 20 per cent in trials. Some analysts estimate that the market for these therapies could hit $150 billion in revenues by the early 2030s.
Both Lilly and Novo are expanding production at current facilities, building or buying new sites for manufacturing and seeking more deals with contract drug manufacturers to increase supply.
Earlier in the day, Lilly said it was investing $4.5 billion to create a new center in Indiana that will focus on developing new ways to manufacture its drugs and increasing production of experimental medicines used in clinical studies.
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