Almost 40 years after an adcomm's warning: FDA and sponsors withdraw approval for anabolic steroid
27 Jun 2023
Drug ApprovalAccelerated Approval
The FDA announced that it’s withdrawing the approval of Gemini Laboratories’ anabolic steroid Oxandrin (oxandrolone) and four generic versions, a decades-old treatment once indicated for the relief of bone pain linked to osteoporosis.
Oxandrin first won FDA approval in 1964. Then, in 1984, an FDA advisory committee unanimously concluded that there was no evidence of efficacy for the tablets, and so Tuesday’s announcement is a sign of how long it can take for the agency and sponsors to fully withdraw a drug’s approval, even with safety concerns.
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Source: EndPoints
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