The "United States," by way of the FDA, does not "approve" drugs for off-label use; licensed doctors may however, prescribe drugs for other indications, if they believe there is sufficient evidence the drug may be safe and effective.
Regulation is a for profit business. I’ve seen the people you hire to help a manufacturer figure out and comply , at like thousands of dollars per day, where the same people that wrote the regulation when they worked in government. You are then inspected by their buddies, and everything is wink wink, nod nod, ‘fine’.
Did anyone else think it was weird that all children’s decongestants were pulled from the shelves in the middle of the night last week because all of a sudden they are “ineffective?” Not a peep from the manufacturers at the cost they will have to eat. This action taken on recommendation of the American Pediatrics Association PRIOR to any FDA action.
My kids took some Mucinex last summer and both experienced kidney failure (thankfully only temporarily). I wouldn’t doubt that the manufacturers have been getting contaminated ingredients, but don’t want to “panic the public.”
Ping of interest.