Almost 40 years after an adcomm’s warning: FDA and sponsors withdraw approval for anabolic steroid

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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