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United Therapeutics resubmits application for pulmonary arterial hypertension drug
SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.
The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.
The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.
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NCHS: OTC switch approval of Plan B broadened access to emergency contraception
ATLANTA — Between 2006 and 2010, 1-in-9 sexually experienced women between the ages of 15 and 44 years had used emergency contraception at least once, the National Center for Health Statistics noted in a report released Wednesday. Use of emergency contraception, such as Plan B One-Step, was the most common among women between the ages of 20 and 24 years, those who never married, Hispanic or non-Hispanic white women, and those who attended college.
That compares with 2-in-5 women who used emergency contraception in 2002 and fewer than 1-in-10 women in 1995.