Prescription Drug Products; Certain Combined Oral Contraceptives for Use as Postcoital Emergency Contraception

摘要

The Food and Drug Administration (FDA) is announcing that the Commissioner of Food and Drugs (the Commissioner) has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception, and requests submission of new drug applications (NDA's) for this use. This notice is intended to encourage manufacturers to make this additional contraceptive option available.