May 13, 2010 -- The FDA says it has approved a new birth control pill called Natazia that is the first four-phase oral contraceptive to be marketed in the United States.
The pill, manufactured by Bayer HealthCare Pharmaceuticals of Wayne, N.J., contains two female hormones -- an estrogen called estradiol valerate and a progestin called dienogest.
Natazia already has been licensed in Europe under the brand name Qlaira.
The FDA says “four-phasic” means the pill delivers varying doses of the progestin and estrogen 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,” Scott Monroe, MD, director of FDA’s Division of Reproductive and Urologic Products, says in a news release. “The approval of Natazia provides another option for women who choose to use an oral contraceptive as their method of contraception.”
The FDA says two studies of 1,867 women found Natazia effective.
Irregular bleeding is one of the most common side effects of Natazia.
Others include breast tenderness, headaches, nausea and vomiting, increased weight, and acne.
The FDA says women older than 35 who smoke should not use Natazia, and cautioned that smoking cigarettes increases the risk of serious cardiovascular events for women using oral contraceptives. Birth control pills do not protect against sexually transmitted diseases, including HIV (the virus that causes AIDS).
Birth control pills have been available for 50 years, but Bayer says Natazia is the first in a new class of oral contraceptives to deliver estradiol valerate, a synthetic estrogen.
“We are very pleased that now women in the U.S. have the option to choose our new oral contraceptive Natazia as an effective option for the prevention of pregnancy,” said Bayer’s Phil Smits, MD, in Berlin. “We are also working with the FDA on an indication for menstrual bleeding disorders to offer women a tailored therapy for this debilitating condition.”
Natazia is expected to be available in the U.S. this summer, Bayer said in a news release issued at the parent company’s main office in Berlin.