Personal Injury Law

Smoker?s Cough Treatment Drug Faces Hurdles in the U.S.

By mbrickley

Swiss drug maker Novartis AG was asked to provide additional information to the Food and Drug Administration about its respiratory drug designed to help smoker’s cough.

The European counterpart to the United States’ FDA has already recommended the drug for approval, and in Europe it will be called Onbrez Breezhaler, according to a Wall Street Journal report.

The drug includes an inhaler to administer the medicine, and it treats chronic obtrusive pulmonary disease (COPD) - the medical name of smoker’s cough. This drug is the first of its kind that only requires one dose daily.

Novartis is willing to work with the FDA to provide any additional information needed to pass the drug for approval in the United States.

Executives for the drug company believe this smoker’s cough treatment will eventually bring in more than $1 billion per year, the Wall Street Journal reported.

The FDA now just has to determine if any more clinical trials need to be completed before approval.To help prevent the occurrence of dangerous or defective drugs, the FDA’s approval process can take longer than companies or consumers might like.

Past testing has proved that the drug noticeably improved lung functions in patients with COPD.

Full post as published by The Injury Blog on October 19, 2009 (boomark / email).