Mylan announced that it has received final approval from the Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Norethindrone Acetate and Ethinyl Estradiol Tablets, 1mg/0.02mg and Ferrous Fumarate, the generic version of Warner Chilcott’s Loestrin 24 Fe.
Loestrin 24 Fe is an estrogen and progestin combination oral contraceptive used to prevent pregnancy. The primary mechanism of action is inhibition of ovulation, and other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).
Mylan has begun shipping this product.
For more information call (800) RX-MYLAN or visit Mylan.com.