The US Food and Drug Administration has removed the active ingredient in Novo Nordisk’s blockbuster diabetes and weight-loss medications Ozempic and Wegovy, semaglutide, from its shortage list.
This follows the pharmaceutical giant’s bid to curb the compounded semaglutide market, with more than 50 lawsuits against compounders, telehealth clinics and medspas for alleged trademark infringement and unfair competition.
As we reported, the GLP-1 drug boom created a lucrative compounder industry, with pharmacies creating off-label duplicates of the drugs for a steep discount compared with the name-brands.
Now, the FDA is giving compounders until 22 April (for state-licensed pharmacies) and 22 May (for larger outsourcing facilities) to cease producing the drug.
Although it is a well-established practice for pharmacists to produce copies of medications in specific dosages or without allergens, some industry players are expected to push back against the latest announcement.
