Irish drugmaker Endo Pharmaceuticals confirmed that the US Food and Drug Administration has approved its long-acting testosterone injection Aveed for treating male hypogonadism.
The FDA had earlier rejected the drug last year, stating that Endo had not provided an adequate risk evaluation and mitigation strategy (REMS) for the product. However the agency and Endo have now come up with an acceptable REMS which is primarily aimed at preventing severe post-injection reactions such as pulmonary oil microembolism (POME) and anaphylaxis.
The product has been approved for use in men who suffer from low testosterone, which is often linked with fatigue, weight gain and low libido. Endo revealed that it has received approval for use of Aveed once every 10 weeks, rather than a weekly or biweekly dose approval given to currently available products.
The approval has received criticism from Public Citizen's Health Research Group who said that recent studies have linked the product with increased risk of cardiovascular disease. However the FDA defended its decision to approve the product, stating that its benefits outweigh the risks. "The FDA's current view is that the benefits of testosterone therapy, including Aveed, outweigh the known risks when used as directed in patients for whom the drug is indicated", FDA spokeswoman Andrea Fischer said.