FDA withdrawal of approval for Oxandrin® and generic oxandrolone tablets

On Jun. 28, 2023, the FDA announced that it is withdrawing its approval for prescription Oxandrin® and generic oxandrolone tablets due to concerns over safety and effectiveness. The FDA determined that potential problems are sufficiently serious that the drug should be removed from the market.

We’re notifying members

Six Priority Health members are impacted by this FDA withdrawal of approval. We’re sending letters this week to those members, asking that they contact their provider for different treatment options, and to dispose of any current or unused products.

What do providers need to do?

If your patients contact you, work with them on alternative treatment options.


More information on this market withdrawal can be found online at federalregister.gov.