FDA panel backs long-acting Boehringer inhaler

(AP)—A panel of federal health experts is overwhelmingly recommending approval for a long-acting inhaler to treat people suffering from chronic lung disease.

The panel voted 15 to one that Boehringer Ingelheim's once-daily inhaler is safe and effective for , a condition that causes bronchitis and emphysema.

The disease affects about 24 million people in the U.S. and is most commonly caused by cigarette smoking. Symptoms include cough, phlegm and shortness of breath.

The FDA is not required to follow the guidance of its panels, though it often does.

German drugmaker Boehringer is also asking the agency to approve the drug called olodaterol with labeling that it increased patients' ability to exercise. If approved, the drug would be the first inhaler with that claim.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Tudorza pressair approved for COPD

Jul 24, 2012

(HealthDay) -- The Tudorza Pressair (aclidinium bromide) inhaler has been approved by the U.S. Food and Drug Administration to treat narrowing of the lung airways associated with chronic obstructive pulmonary disease (COPD) ...

FDA panel unanimously votes down Parkinson's drug

Oct 17, 2011

A panel of federal medical specialists has unanimously voted that a drug for Parkinson's disease from Teva Pharmaceuticals has not been shown to slow progress of the debilitating neurological disease.

FDA phases out inhaler due to environmental impact

Sep 22, 2011

(AP) -- Asthma patients who rely on over-the-counter inhalers will need to switch to prescription-only alternatives as part of the federal government's latest attempt to protect the Earth's atmosphere.

FDA panel unanimously backs Regeneron eye drug

Jun 17, 2011

(AP) -- A panel of federal health experts voted unanimously in favor of a new eye drug from Regeneron, bringing the company one step closer to competing against a blockbuster Roche drug that currently dominates the market.

Recommended for you

Using computers to design drugs

5 hours ago

Designing a new medicine is an expensive and time consuming business. Typically it takes around $2 billion and ten years for a new drug to move from its initial design in the lab, to the clinic. All the ...

Lilly psoriasis drug fares well in late-stage test

9 hours ago

Drugmaker Eli Lilly and Co. said its potential psoriasis treatment fared better than both a fake drug and a competitor's product during late-stage testing on patients with the most common form of the skin disease.

New US restrictions on painkiller to take effect

22 hours ago

The federal government is finalizing new restrictions on hundreds of medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

User comments