FDA Oops: Steroid Tablets Oxandrin and Generics Yanked for Safety Reasons
Published Date: 10/7/2026
Notice
Summary
The FDA fixed a previous announcement about Oxandrin tablets (2.5 mg and 10 mg) being pulled from the market due to safety or effectiveness concerns. This update confirms that not only the original drug but also several generic versions were withdrawn and removed from the official drug list. Patients, doctors, and drug makers should note these changes, which affect availability and prescribing options immediately.
Analyzed Economic Effects
2 provisions identified: 0 benefits, 2 costs, 0 mixed.
Oxandrin tablets withdrawn for safety
The FDA determined that Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg (NDA 013718), were withdrawn from sale for reasons of safety or effectiveness. FDA announced withdrawal of approval for NDA 013718 effective June 28, 2023.
Generic ANDAs referencing Oxandrin removed
FDA determined that abbreviated new drug applications (ANDAs) that referenced Oxandrin were also withdrawn for reasons of safety or effectiveness and will be removed from the Orange Book. The affected ANDAs include Par Pharmaceutical Inc. (ANDA 077827), Roxane Laboratories, Inc. (ANDA 077249; withdrawal effective June 18, 2009), Sandoz Inc. (ANDA 076897), and Upsher Smith Laboratories LLC (ANDAs 076761 and 078033); removals were announced effective June 28, 2023 for the listed ANDAs.
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