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FDA Proposes to Exclude Semaglutide, Tirzepatide, Liraglutide From 503B Bulks List

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-- The US Food and Drug Administration said Thursday it is proposing to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound the drugs from bulk substances.

Novo Nordisk (NVO) manufactures semaglutide, marketed as Ozempic for type 2 diabetes and Wegovy for chronic weight management, and liraglutide, under the brand name Victoza for type 2 diabetes and Saxenda for chronic weight management. Eli Lilly (LLY) manufactures tirzepatide, marketed as Mounjaro for type 2 diabetes and Zepbound for chronic weight management.

Normally, outsourcing facilities cannot compound drugs using bulk drug substances unless the substance is on the 503B bulks list or the compounded drug is on the FDA's drug shortage list at the time of compounding, distribution, and dispensing, the FDA said.

Novo Nordisk and Eli Lilly didn't immediately reply to requests for comment from.

Price: $42.48, Change: $+2.19, Percent Change: +5.44%

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