Why Is Dutasteride Not Approved by the FDA in the Us?

At this point, I doubt Dutasteride would ever be approved for hair loss as the 0.5mg is already generic. Why would a drug company go through expensive trials to get a second indication when the drug is off patent? They would have had to get it approved at the same time as BPH in order for them to make money.  For now, people in Canada and the USA or going to have to get it off label or order it online which sucks. Makes it harder to get for most of us.

To get the FDA to approve dutasteride, the company that manufactures it must put in the application, and fight for it. They don’t seem to be interested.