Content about Pulmonary hypertension

February 14, 2013
United Therapeutics resubmits application for pulmonary arterial hypertension drug

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 launches PAH drug

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
FDA approves Mylan pulmonary arterial hypertension drug

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
FDA approves Watson PAH drug

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
FDA declines approval of United Therapeutics PAH drug

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
United Therapeutics awaits FDA decision on oral PAH drug as Sandoz seeks generic approval

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
FDA lifts liver injury risk boxed warning from Gilead's Letairis

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 acquires rights to terguride

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