FDA approves testosterone gel 1% for hypogonadism

The FDA announced it has approved the new drug application for testosterone gel 1% indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, according to a press release.

According to FDA documents, the schedule 3 controlled substance (AndroGel 1%, Perrigo Company) has also been approved for a risk evaluation and mitigation strategy (REMS) to ensure the benefits of the drug outweigh the risks for secondary exposure due to drug transfer from adult males using testosterone gel products to children.

For more information:

FDA approval. NDA 203098.