A US judge has denied an injunction request from a compounding industry group challenging the FDA’s decision regarding the availability of semaglutide, the active ingredient in Ozempic. Compounders, who replicate brand-name drugs in short supply, argued that there is still a shortage of semaglutide. However, the FDA maintains that Novo Nordisk, the manufacturer of Ozempic, has sufficient supply to meet demand. The court’s decision upholds the FDA’s timeline, which requires large compounders to exit the market by May. Smaller compounding pharmacies must immediately stop producing copies of semaglutide. The judge sealed his reasoning, but evidence presented by the compounders was not considered in this decision. The FDA had previously stated it would not enforce actions against compounders until the court made its ruling.
— new from Reuters
