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FDA Approves New Combination Product Oral Contraceptive
ROCKVILLE, Md -- May 6, 2010 -- The US Food and Drug Administration (FDA) has approved a combination hormonal tablet for use as an oral contraceptive (Natazia).
The tablet contains 2 female hormones, an oestrogen (oestradiol valerate) and a progestin (dienogest), and is the first 4-phasic oral contraceptive marketed in the US.
"The approval of Natazia provides another option for women who choose to use an oral contraceptive as their method of contraception," said Scott Monroe, MD, FDA's Division of Reproductive and Urologic Products, Rockville, Maryland.
The safety and efficacy of the oral contraceptive was evaluated in 2 multicentre phase 3 trials in North America and Europe. The trials involved 1,867 women and nearly 30,000 28-day treatment cycles. The contraceptive was found to be effective as a hormonal contraceptive in both studies.
The most common side effects observed included irregular bleeding, breast tenderness, headaches, nausea and vomiting, increased weight, and acne.
SOURCE: US Food and Drug Administration
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