A key part of this battle has been won. It is far from over.
The agency wrote that Barr had two choices to get its application approved. Either it can undertake a new study among girls 16 years old and younger to show that they can use the drug safely without the help of a doctor. Or the company must write a new label and construct a system that would allow women older than 16 to buy the drug over the counter while those younger than 17 would be forced to get a prescription.