FDA approves combination oral contraceptive

July 1, 2010

The US Food and Drug Administration recently approved Natazia, a 4-phasic combination oral contraceptive containing the progestin dienogest and a synthetic estrogen, estradiol valerate.

The US Food and Drug Administration recently approved Natazia (Bayer HealthCare Pharmaceuticals), a 4-phasic combination oral contraceptive containing the progestin dienogest and a synthetic estrogen, estradiol valerate, which is converted to estradiol in a woman's body. Taken once daily, the dosing regimen consists of pills with varying doses of estradiol valerate and estradiol valerate/dienogest on specific days of a 28-day cycle.

Natazia is licensed in Europe under the brand name Qlaira.

Two multicenter, phase 3 clinical trials conducted in North America and Europe demonstrated the product's safety and efficacy as a combination oral contraceptive. The trials involved 1,867 women and nearly 30,000 28-day cycles. The most common treatment-related adverse effects were irregular bleeding, breast tenderness, headaches, nausea and vomiting, increased weight, and acne.

US Food and Drug Administration. FDA approves new combination product oral contraceptive [press release]. May 6, 2010. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm211176.htm. Accessed June 22, 2010.

Bayer HealthCare Pharmaceuticals. Natazia receives FDA approval–May 6, 2010 [press release]. http://www.natazia.com/scripts/pages/pressrelease.php. Accessed June 22, 2010.