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FDA Approves Orenitram (treprostinil) Extended-Release Tablets for the Treatment of Pulmonary Arterial Hypertension
Posted 8 Jan 2014 by Drugs.com
SILVER SPRING, Md., Dec. 20, 2013 /PRNewswire/ – United Therapeutics Corporation announced today that the United States Food and Drug Administration (FDA) has approved Orenitram (treprostinil) Extended-Release Tablets for the treatment of pulmonary arterial hypertension (PAH) in WHO Group I patients to improve exercise capacity. "This approval marks the first time that the FDA has approved an orally administered prostacyclin analogue for any disease — and our fifth approval from the FDA for treatment of PAH — supporting our mission of providing a wider choice of PAH therapies for physicians and patients," said Roger Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer. "We are grateful for the FDA's thorough review and will continue to build clinical support for the use of Orenitram." The primary efficacy study, FREEDOM-M, demonstrated that patients receiving Ore ... Read more
Posted 16 Sep 2011 by Drugs.com
FRIDAY, Sept. 16 – Despite ongoing prevention efforts, a growing number of young children are being accidentally poisoned with medications, according to new research. The study, which was based on data reported to the American Association of Poison Control Centers between 2001 and 2008, found that medication poisoning among children aged 5 and under increased by 22 percent, although the number of children in the United States in this age group rose by only 8 percent during the study period. "The problem of pediatric poisoning in the U.S. is getting worse, not better," Dr. Randall Bond, of Cincinnati Children's Hospital Medical Center, said in a hospital news release. In conducting the study, which is scheduled for publication in the Journal of Pediatrics, the researchers reviewed information on over 544,000 children who landed in the emergency department due to medication poisoning ... Read more
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