US food And the administration of the drug has shown that Samglotide is no longer deficient, which will have consequences for patients who take cheaper and a combination of the drug.
SemagluTide, active element in diabetes climbing, and Ozempic and Wegovy weight loss drugs, have been on the FDA deficiency list since March 2022. Supply cannot be accompanied by intense drug demand, which has reached such a confusing level of popularity. This Novo Nordisc has made it one of the most valuable companies in the world, with an investment in the market larger than the rest of the nation’s home economy of Denmark.
During the intervention years, a lucrative industry from telecommunications companies, medical spa and pharmacies has been produced and sold for “hybrid” prescriptions of drugs. These versions of the brand are sold at a sloping discount-sometimes under $ 100 vials-with branded brands, which can be more than $ 1,000 a month without insurance.
In late October, the FDA changed the status of all ozempic and wegovy doses to “available”, indicating that the end of the formal shortage is likely to be exposed. To date, it took about four months later for the regulators to conclude that the drug was widely available to remove it from the deficiency list.
The FDA gives the “503A” compositions, government -licensed pharmacies or physicians who perform smaller operations until April 22 April. These compounds provide you with “503b”, which have more outsourcing capabilities that follow the more strict production instructions, until May 22.
Under normal circumstances, when drugs are out of the shortage list, it is not particularly controversial. But there is a reason to believe that the players in the industry are returning to the announcement.
The composition of the drug is a fully stabilized action. If there is a lack of medication or when patients need versions made in specific or without allergens, pharmacists are allowed to prescribe prescriptions. But the GLP-1 boom has created an opportunity for combinants that have changed the pockets of the industry, and combined pharmacies that produce out-of-brand versions for millions of patients.
Robert McArtor, director of pharmacy at the University of Rockefeller, says pharmacies that create large categories of composite drugs for health care centers as soon as a drug is removed from the FDA deficiency list. Form the drug. But for smaller and traditional hybrid pharmacies that create medicines for home use, this is a legal gray area.
“If the doctor writes a prescription for a personal patient, they can complicate it and feel there is a compelling reason why the patient needs that particular product,” says McArtor. This can be the cause of the dose or sewing of the drug to a particular patient.
In December, the FDA announced that Tirzepatide, the other popular GLP-1 drug, is no longer deficient. The small 503A compounders had 60 days to stop production, while the larger outsourcing facilities of 503B had 90 days for packaging. Eli Lily, who sells Tirzepatide under the brand names Mourse and Zepbound, sent hundreds of hybrids, stop letters and desist. The composite industry was pushed back and formed a business group with a lawsuit against the FDA, saying that access to the drug was still difficult for patients. The FDA has already set deadlines for the compositions to stop the production of Tirzepatide products, but with the continuation of the petition, the deadlines do not execute the deadlines right now.
