MADRID (Reuters) – the administration of food and medicines of United States ( FDA) requested three months more to review the application for approval of the drug bromide of aclidinio by Almirall and Forest, said Thursday the lab Spanish.
“the response of the FDA is expected in July of 2012,” said Almirall said in a statement.
In February, an Advisory Committee supported the efficacy of the drug, indicated to treat lung disease chronic (COPD) obstructive, and its experts said that it contributes to help patients breathe better.
However, requested that companies conduct surveys to check if there are safety hazards because some patients died from heart problems during the trials.
Almirall has also requested approval for the drug in Europe, where he also expects a response this year.
(Report of Rodrigo de Miguel); (Edited by Robert Hetz and Ana Laura Mitidieri)
