Qlaira; estradiol valerate/dienogest tablets to be sold in the U.S as Natazia
U.S. FDA Approves Natazia(TM), a New Oral Contraceptive for the Prevention of Pregnancy
05.07.10, 08:06 AM EDT
PRNewswire
“WAYNE, N.J., May 7 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Natazia (TM) (estradiol valerate and estradiol valerate/dienogest) tablets for the prevention of pregnancy. Natazia has not been evaluated in women with a BMI of greater than 30 kg/m(2) [the equivalent of a 5’7” woman weighing 190 lbs]. Natazia is the first and only oral contraceptive that contains an estrogen called estradiol valerate and a progestin called dienogest. Estradiol valerate is a synthetic estrogen that is converted to estradiol in a woman's body. Natazia is expected to be available in the summer.
Until today, all marketed combination oral contraceptives (COCs) contained ethinyl estradiol. With the FDA approval of Natazia, Bayer HealthCare Pharmaceuticals becomes the first company [in the U.S.] to launch estradiol valerate together with the progestin, dienogest.
"Every woman's body reacts differently to hormones, so it is important that they have a choice in birth control options," said Anita Nelson, MD, professor of obstetrics and gynecology at the Harbor-UCLA Medical Center, Torrance, California. "Natazia may be a good option for women to consider when making a decision with their healthcare provider about which birth control option is right for them."
Women using COCs, including Natazia, should be strongly advised not to smoke. Smoking increases the risk of serious cardiovascular side effects from COC use. The risk increases with age and the number of cigarettes, especially in women over 35 years old.
Natazia is taken once a day. The dosing regimen consists of pills with varying doses of estradiol valerate, and estradiol valerate in combination with dienogest, for specific days of the 28-day cycle.” The text in brackets [ ] was added by me for clarification.
Personal comment: I think Natazia should be available from U.S. pharmacies some time in the 3rd quarter of this year. It comes at a good time for Bayer because Yasmin/Yaz is under pressure from lawsuits claiming injury from side effects caused by the progestin drospirenone. Qlaira became available in Europe in May of 2009. Women interested in the patient information leaflet for Natazia are (for now) being referred to the Qlaira PIL at Qlaira.
U.S. FDA Approves Natazia(TM), a New Oral Contraceptive for the Prevention of Pregnancy
05.07.10, 08:06 AM EDT
PRNewswire
“WAYNE, N.J., May 7 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Natazia (TM) (estradiol valerate and estradiol valerate/dienogest) tablets for the prevention of pregnancy. Natazia has not been evaluated in women with a BMI of greater than 30 kg/m(2) [the equivalent of a 5’7” woman weighing 190 lbs]. Natazia is the first and only oral contraceptive that contains an estrogen called estradiol valerate and a progestin called dienogest. Estradiol valerate is a synthetic estrogen that is converted to estradiol in a woman's body. Natazia is expected to be available in the summer.
Until today, all marketed combination oral contraceptives (COCs) contained ethinyl estradiol. With the FDA approval of Natazia, Bayer HealthCare Pharmaceuticals becomes the first company [in the U.S.] to launch estradiol valerate together with the progestin, dienogest.
"Every woman's body reacts differently to hormones, so it is important that they have a choice in birth control options," said Anita Nelson, MD, professor of obstetrics and gynecology at the Harbor-UCLA Medical Center, Torrance, California. "Natazia may be a good option for women to consider when making a decision with their healthcare provider about which birth control option is right for them."
Women using COCs, including Natazia, should be strongly advised not to smoke. Smoking increases the risk of serious cardiovascular side effects from COC use. The risk increases with age and the number of cigarettes, especially in women over 35 years old.
Natazia is taken once a day. The dosing regimen consists of pills with varying doses of estradiol valerate, and estradiol valerate in combination with dienogest, for specific days of the 28-day cycle.” The text in brackets [ ] was added by me for clarification.
Personal comment: I think Natazia should be available from U.S. pharmacies some time in the 3rd quarter of this year. It comes at a good time for Bayer because Yasmin/Yaz is under pressure from lawsuits claiming injury from side effects caused by the progestin drospirenone. Qlaira became available in Europe in May of 2009. Women interested in the patient information leaflet for Natazia are (for now) being referred to the Qlaira PIL at Qlaira.
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