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FDA declines approval of United Therapeutics PAH drug
SILVER SPRING, Md. — The Food and Drug Administration has declined to approve a drug developed by United Therapeutics Corp. for treating a potentially lethal high blood pressure condition.
The drug maker said it received a complete response letter from the agency for its application for a tablet formulation of the drug treprostinil. The company already markets the drug in injectable and inhaled formulations for pulmonary arterial hypertension, or PAH, a condition that causes high blood pressure in the arteries of the lungs.
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FDA approves Par leukemia drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.
Par said Thursday that the FDA had approved Anchen Pharmaceuticals' tretinoin capsules in the 10-mg strength.
The drug is a generic version of Roche's Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.