FDA approves new birth control pill Natazia
Fri, May 7 2010
WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Thursday it approved Bayer AG's new birth control pill Natazia.
The pill, already licensed in Europe under the brand name Qlaira, is the first four-phase oral contraceptive marketed in the United States, the FDA said.
It delivers varying doses of the hormones progestin 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 the FDA's Dr. Scott Monroe.
"The approval of Natazia provides another option for women who choose to use an oral contraceptive as their method of contraception."
Two studies of 1,867 women found Natazia was effective, with many of the same side effects as other birth control pills, the FDA said.
Asked by Anonymous at 5:59 PM on May. 8, 2010 in Health
Answer by Jademom07 at 6:05 PM on May. 8, 2010
Answer by Anonymous at 5:59 PM on May. 8, 2010
"So what then makes this particular pill different from the others already on the market? Well, Natazia becomes the first oral contraceptive that will be marketed in the US that is a four phase contraceptive. What this means is that during a woman’s 28 day cycle, this pill will deliver different levels of hormones four times a month to its user. It is also different from the other contraceptives in that it is the first one to contain an estrogen called estradiol valerate combined with a progestin called dienogest. This was unheard of in the oral contraceptive market in its combination pills, which usually contained only ethinyl estradiol. "
Answer by Anonymous at 6:03 PM on May. 8, 2010
"Natazia needs to be taken once a day. It delivers varying doses of hormones at four times throughout each 28-day treatment cycle. Specifically, 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. Each blister pack of Natazia contains the following pills that must be taken in this specific order: 2 dark yellow tablets each containing 3 mg estradiol valerate, 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest, 17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest, 2 dark red tablets each containing 1 mg estradiol valerate, and 2 white tablets (inert/placebo) tablets."
Answer by Anonymous at 6:07 PM on May. 8, 2010
Answer by SabrinaMBowen at 6:08 PM on May. 8, 2010
Answer by Ctink8189 at 6:11 PM on May. 8, 2010
With the name Qlaira is how Natazia was marketed in Europe
Answer by Anonymous at 6:13 PM on May. 8, 2010
Answer by Anonymous at 6:16 PM on May. 8, 2010
"Bayer is so far focusing its marketing on the estradiol component of Qlaira®, which is unique. It is the first oral contraceptive to use an essentially natural estrogen. However, pretending that this makes it a “natural” contraceptive by ignoring the dienogest is misleading. It’s likely that if this product isn’t already in the U.S. FDA pipeline awaiting approval (possibly under a different name), it will be, and the marketing will undoubtedly follow the same twisted path. Buyer be aware."
Answer by Anonymous at 6:17 PM on May. 8, 2010
Answer by Anonymous at 6:24 PM on May. 8, 2010
Next question overall
Well ladies after thinking everything over in my life, I am offically coming...