OzemPIC deficiency has ended

US food And drug administration It has been identified Which – which semaglutide no longer In deficiencyAnd a step that will have effects on patients who take cheaper and vehicle versions of the drug.

Semaglutide, the active ingredient in Novo Nordsk Profitable diabetes and weight loss medications Ozmpic and WegovyIt was on FDA List of deficiency since March 2022. It cannot keep pace with the offer Severe request for medicineThat has reached amazing levels of popularity to the point that it turned Novo Nordisk into one of the most valuable companies in the world, with Market value More than the rest of the nation’s economy in Denmark.

In the decisive years, Profitable For remote healthcare companies, medical resorts, and pharmacies Make and sell “vehicle” copies From the medications I grew up. These copies are sold out of the brand with a sharp discount-sometimes less than $ 100 per bottle-the brand medications, which can exceed $ 1,000 per month without insurance.

At the end of October, the Food and Drug Administration (FDA) changed the condition of all OzemPic and Wegov doses to “available”, indicating that the end of the official shortage is likely to be on the horizon. It took it to this day, about four months later, until the organizers conclude that the drug was widely available enough to remove it from the deficiency list.

Food and Drug Administration It gives “503A” complexes, usually licensed pharmacies from the state or doctors ’complexes that manage smaller operations, until April 22 to stop producing the drug. It gives 503B complexes, which are the facilities of using the largest external sources that track tougher manufacturing guidelines, until May 22.

Under normal circumstances, it is not particularly controversial when drugs are launched in the deficiency list. But there is a reason for the belief that players in this industry will return to this announcement.

Drug double is a solid practice. Pharmacists are allowed to create copies of medications when there is a lack of drugs or when patients need versions made in specific doses or without allergies. But the GLP-1 mutation has created an opportunity for vehicles that transformed the pockets of industry, as compound pharmacies produce repetitions outside the brand of potential millions of patients.

Robert McA Arter, director of pharmacy at the University of Rockefeller Hospital, says that once a medicine comes out of the FDA deficiency list, pharmacies use external sources that make large batches of compound medicines for healthcare facilities no longer supposed to outperform this medicine. But for smaller pharmacies and traditional vehicles that make medicines for home use, they are a legal gray area.

“They can assemble it if the doctor writes a prescription for an individual patient and feels that there is a convincing reason for the patient’s needs in this special compound product,” says Mac Arthur. This reason can be to adjust the dose or allocate the drug to a specific patient.

In December, the FDA announced that Tirzepatide, the other popular GLP-1, is no longer a shortage. The small 503A complexes had 60 days to stop production, while the facilities of the use of larger 503B external sources had 90 days to finish sales. Eli Lilly, who sells Tirzepatide under commercial names The letters of stopping work For hundreds of companies that sell compound versions. The industry pushed the compound back, as a commercial group filed a lawsuit against the Food and Drug Administration (FDA), on the pretext that the drug was still difficult to reach patients. As of now, the Food and Drug Administration has set the final dates for vehicles to stop producing Tirzepatide products, but it does not implement the final dates at the present time with the continuation of the lawsuit.