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FDA approves Bayer IUD
WAYNE, N.J. — The Food and Drug Administration has approved a new intrauterine device for preventing pregnancy made by Bayer HealthCare Pharmaceuticals, the drug maker said.
Bayer announced the approval of Skyla (levonorgestrel-releasing uterine system), which can prevent pregnancy for up to three years. The IUD contains 13.5 mg of levonorgestrel.
Nearly 50% of pregnancies in the United States are unintended, according to the National Center for Health Statistics.
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FDA calls for lower dosage in some insomnia drugs
SILVER SPRING, Md. — The Food and Drug Administration is ordering the makers of several sleep drugs to lower the recommended dosage due to the risk that they can impair patients the morning after, the agency said Thursday.
The FDA announced that it was requiring the manufacturers of drugs containing the active ingredient zolpidem to lower the current recommended dosage in light of new data showing that the morning after use, the drug can remain in the blood in sufficient quantities to impair activities that require alertness, such as driving.