Content about Pulmonary hypertension

December 23, 2013

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

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.

October 21, 2013

The Food and Drug Administration has approved a new drug made by Actelion Pharmaceuticals for treating pulmonary arterial hypertension.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Actelion Pharmaceuticals for treating pulmonary arterial hypertension.

The agency announced the approval of Opsumit (macitentan) for adults with PAH, a chronic, progressive and debilitating disease caused by high blood pressure in the arteries that connect the heart to the lungs that can lead to death or the need for lung transplantation.

October 9, 2013

The Food and Drug Administration today approved Adempas, also known as riociguat, to treat adults with two forms of pulmonary hypertension, which is caused by abnormally high blood pressure in the arteries of the lungs.

SILVER SPRING, Md. — The Food and Drug Administration today approved Adempas, also known as riociguat, to treat adults with two forms of pulmonary hypertension, which is caused by abnormally high blood pressure in the arteries of the lungs.

February 14, 2013

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.

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.

November 19, 2012

Dr. Reddy's Labs has launched a generic drug for treating pulmonary arterial hypertension, the company said.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic drug for treating pulmonary arterial hypertension, the company said.

Dr. Reddy's announced the launch of sildenafil tablets in the 20 mg strength in 90-count bottles. The drug is a generic version of Pfizer's Revatio.

Revatio had sales of $338.67 million during the 12-month period ended in September, according to IMS Health.

November 13, 2012

The Food and Drug Administration has approved a generic drug made by Mylan for treating pulmonary arterial hypertension, the drug maker said Tuesday.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan for treating pulmonary arterial hypertension, the drug maker said Tuesday.

Mylan announced the FDA approval of sildenafil citrate tablets in the 20-mg strength, a generic version of Pfizer's Revatio. The drug is used to treat adults with PAH to improve exercise ability and delay clinical worsening of the condition.

Revatio had sales of about $339 million during the 12-month period ended in September, according to IMS Health.

November 12, 2012

The Food and Drug Administration has approved a generic drug for pulmonary arterial hypertension made by Watson Pharmaceuticals, the drug maker said Monday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug for pulmonary arterial hypertension made by Watson Pharmaceuticals, the drug maker said Monday.

Watson said the FDA approved its sildenafil tablets in the 20 mg strength through a subsidiary. Watson said it would launch the drug "in the near future."

The drug is a generic version of Pfizer's Revatio tablets, which had sales of about $339 million during the 12-month period ended in September, according to IMS Health.

October 25, 2012

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.

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.

October 23, 2012

The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

NEW YORK — The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

March 4, 2011

Gilead on Friday announced that the Food and Drug Administration has removed a boxed warning about a possible liver injury risk caused by the drug maker's hypertension treatment.

FOSTER CITY, Calif. — Gilead on Friday announced that the Food and Drug Administration has removed a boxed warning about a possible liver injury risk caused by the drug maker's hypertension treatment.

Gilead said the FDA approved a change to the prescribing information for Letairis (ambrisentan 5-mg and 10-mg tablets), the company’s once-daily treatment of pulmonary arterial hypertension.

May 11, 2010

Pfizer will acquire worldwide rights to a drug for treating pulmonary arterial hypertension, the drug...