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US judge ruling for FDA bars copies of Lilly weight loss drug

US judge ruling for FDA bars copies of Lilly weight loss drug

US judge ruling for FDA bars copies of Lilly weight loss drug

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By Patrick Wingrove

(Reuters) -A U.S. federal judge has denied an injunction that would have allowed compounding pharmacies to keep making copies of Eli Lilly’s popular weight-loss drug Zepbound in the U.S.

The decision was filed late on Wednesday in response to an October lawsuit from a compounding industry group against the U.S. Food and Drug Administration’s decision to bar those copies.

Compounding pharmacies that have been selling hundreds of thousands of doses of copies of Zepbound while the medicines were in shortage are now running out of time to produce them.

Smaller compounding pharmacies that are largely overseen by U.S. states must immediately cease making copies of tirzepatide, while larger pharmacies regulated by the FDA have until March 19.

U.S. regulations allow compounding pharmacies to manufacture and sell large quantities of brand-name medicines only if they are in short supply.

The FDA first announced in October that Lilly’s Zepbound and diabetes drug Mounjaro, both known chemically as tirzepatide, were out of shortage before reaffirming that decision in December.

(Reporting by Patrick Wingrove in New York, Editing by Franklin Paul)

Brought to you by www.srnnews.com

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