So it’s only certain use cases? Or certain “versions” of the tablets? I’m not sure I’m getting this.
Also, I find it funny that the FDA found lack of evidence for efficacy way back in ‘84, but they’re just now doing this.
Oxandrolone had already been approved by the FDA to help relieve bone pain in 1964 for osteoporosis.
In 1984, an FDA committee decided that there was not enough evidence for the efficacy of tablets - not the drug, just in tablet form.
And also for context, these types of committee decisions weigh the effectiveness by the standards of the time so something that helped by 1964's standards may be far less impressive 20 years later as compared to other available options.
The reason that they're 'just now doing this' is that the pharmaceutical company that had the application asked the FDA to withdraw the application. The FDA didn't just do it on their own - the pharmaceutical company asked them to.
That would normally indicate that the pharma company didn't view it as viable anymore for the drug to prescribed for the the desired application. That doesn't mean they're saying it doesn't work for other things, it actually doesn't mean that they're saying it doesn't even work for that; just that its not viable to continue to prescribe for that purpose. Which I would agree with in this case, because its been so long since its been prescribed for pain in osteoporosis that most people probably don't realize that it ever even was.
I hope that makes sense and helps clarify it. Stuff like this can be super confusing to understand the terminology.