Content about Phosphodiesterase inhibitors

April 27, 2012
FDA approves Vivus' Stendra for erectile dysfunction

The Food and Drug Administration has approved a new drug for treating erectile dysfunction, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating erectile dysfunction, the agency said Friday.

The FDA announced the approval of Vivus' Stendra (avanafil).

"This approval expands the available treatment options to men experiencing erectile dysfunction and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs," FDA Office of Drug Evaluation III deputy director Victoria Kusiak said.

September 7, 2011
FDA accepts new drug application from Vivus

The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

Vivus said it expected the Food and Drug Administration to complete its review of the application for avanafil by April 29, 2012.

"We are pleased with FDA's acceptance of our NDA," Vivus president Peter Tam said. "If approved, avanafil could be a valuable treatment alternative for the 18 million men in the United States that suffer from ED."

June 10, 2011
Forest announces availability of Daliresp

A drug for chronic obstructive pulmonary disease made by Forest Labs will be available by the middle of this month, Forest said Thursday.

NEW YORK — A drug for chronic obstructive pulmonary disease made by Forest Labs will be available by the middle of this month, Forest said Thursday.

Daliresp (roflumilast) recently received approval from the Food and Drug Administration as a treatment to reduce the risk of exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Forest said Daliresp, a daily oral tablet, is the first and only approved drug in its class, known as selective phosphodiesterase-4 inhibitors.