FDA to reconsider decision to ban compounded version of Eli Lilly’s weight loss drug | Wilnesh News

The U.S. Food and Drug Administration agreed Friday to reconsider its decision last month to ban drug formulators from selling their own versions of their drugs. Eli Lilly and Company Blockbuster Weight Loss and Diabetes Drugs.

The agency said in a court filing that it will now allow compounding pharmacies and facilities to continue offering the drugs while it reviews whether there are any shortages of their active ingredients. For patients, compounded versions of these drugs are less expensive than brand-name drugs.

The decision was made in response to a lawsuit The Outsourcing Facilities Association, a composite industry group, filed the lawsuit on Monday. U.S. District Judge Mark Pittman in Fort Worth, Texas, put the lawsuit on hold after the FDA decided Friday to reconsider.

The FDA’s Sept. 30 decision jeopardizes compounders’ ability to sell versions of Eli Lilly’s diet drug Zepbound and diabetes drug Mounjaro. FDA decision Removed their active ingredientstilsiparatide, from its short list of drugs.

This will leave many patients without access to the compound medications they rely on during shortages, which are less expensive than brand-name medications. Insurers often cover diabetes medications such as tirsiparatide, but many do not cover weight-loss drugs.

Lee Rosebush, president of the Outsourcing Facilities Association, said in a statement that the organization is “extremely relieved that the FDA has agreed to reconsider its decision, bringing great relief to our members and the many patients they serve.”

If a drug is in short supply, federal regulations allow the sale of compounded versions of FDA-approved drugs to meet demand. Without a shortage of a drug, it would be impossible to produce compounded versions of that drug on a regular basis or in large quantities.

The Outsourcing Facilities Association claims in the lawsuit that the FDA removed tilsiparatide from its shortage list, even though it remains in short supply.

August Lily Start sending cease and desist letters Telemedicine companies, wellness centers and medical spas selling combined versions of Zepbound and Mounjaro. The company also owns File a lawsuit Target sellers who falsely claim to be selling FDA-approved versions of drugs.

Its active ingredient is Novo Nordisk The drug semaglutide remains on the FDA’s shortage list.