Regulatory and Washington

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by United Therapeutics for treating pulmonary arterial hypertension, the company said Monday.

The FDA approved Orenitram (treprostinil) extended-release tablets for treating certain PAH patients to improve exercise capacity. PAH is a disease in which abnormally high blood pressure in the arteries of the lungs causes the right side of the heart to work harder than normal, according to the National Library of Medicine.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment made by Danish drug maker Novo Nordiskfor a rare, genetic bleeding disorder, the agency said Monday.

NEW YORK — While more than half of Americans don't agree with legalizing the sale and possession of small amounts of marijuana for recreational use, most also say that if legal, it should be sold at pharmacies, according to a new survey.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday announced the need for legislation in Pennsylvania to protect independent pharmacy operators there. 

SILVER SPRING, Md. — The Food and Drug Administration and the European Medicines Agency will share data about studies meant to show whether generic drugs are equivalent to their branded counterparts, under a joint program announced Wednesday.

WASHINGTON — The U.S. healthcare system saved $217 billion in 2012 thanks to the use of generic drugs, according to a new report by a generic drug industry trade group.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by GlaxoSmithKline and Theravance for treating chronic obstructive pulmonary disease, the agency said Wednesday.

The FDA announced the approval of Anoro Ellipta (umeclidinium; vilanterol inhalation powder) as a once-per-day maintenance treatment for airflow obstruction in patients with COPD, a term that encompasses chronic bronchitis and emphysema; smoking is the leading cause of COPD in the United States.

BALTIMORE — Lupin has launched a generic drug for treating HIV, following its victory in a patent-infringement suit in federal court, the Indian drug maker said Wednesday.

Lupin's U.S. subsidiary launched its generic version of ViiV Healthcare's Trizivir (abacavir sulfate; lamivudine; zidovudine) tablets in the 300-mg/150-mg/300-mg strength. The launch follows a ruling by the U.S. District Court for the District of Delaware that the drug did not infringe on Viiv's patent.