Officials said Natazia contains two female hormones -- an estrogen (estradiol valerate) and a progestin (dienogest) -- and is the first four-phasic oral contraceptive marketed in the United States. The FDA said "four-phasic" refers to the doses of progestin and estrogen varying at four times throughout each 28-day treatment cycle.
"Nearly 12 million women in the United States and more than 100 million women worldwide currently use oral contraceptives," said Dr. Scott Monroe, director of the FDA's Division of Reproductive and Urologic Products. "The approval of Natazia provides another option for women who choose to use an oral contraceptive as their method of contraception."
The federal agency noted women older than 35 who smoke shouldn't use the product. The FDA said cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use.
Natazia is manufactured by Bayer HealthCare Pharmaceuticals of Wayne, N.J.