The FDA has previously approved medical devices – including prosthetics – that have been 3D printed.
The new drug, dubbed Spritam, was developed by Aprecia Pharmaceuticals to control seizures brought on by epilepsy.
The company said that it planned to develop other medications using its 3D platform.
Printing the drugs allows layers of medication to be packaged more tightly in precise dosages.
A separate technology developed by the firm, known as ZipDose, makes high-dose medications easier to swallow.
Printing the drug meant it could package up to 1,000 milligrams into individual tablets.
The 3D-printed pill dissolves in the same manner as other oral medicines.