Navigation Links
FDA Approves Arcapta Neohaler to Treat Chronic Obstructive Pulmonary Disease
Date:7/1/2011

SILVER SPRING, Md., July 1, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Arcapta Neohaler (indacaterol inhalation powder) for the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

COPD is a serious lung disease that makes breathing difficult. Symptoms can include breathlessness, chronic cough and excessive phlegm. Cigarette smoking is the leading cause of COPD, and is the fourth leading cause of death in the United States, according to the Centers for Disease Control and Prevention.

Arcapta Neohaler is a new molecular entity in the beta2-adrenergic agonist class that helps muscles around the airways of the lungs stay relaxed to prevent symptoms of COPD, such as wheezing and breathlessness. Arcapta Neohaler is not intended to treat asthma or sudden, severe symptoms of COPD.

"The approval of new long-term drugs for COPD that relieve breathing difficulty by opening airways provides another treatment option for the millions of people," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.

The safety and efficacy of Arcapta Neohaler was demonstrated in six confirmatory clinical trials that included 5,474 patients ages 40 and older with a clinical diagnosis of COPD. Those treated had a smoking history of at least one pack a day for 10 years and exhibited moderate-to-severe decreases in lung function.

Arcapta Neohaler carries a boxed warning that long-acting beta2 adrenergic agonists (LABA) increase the risk of asthma-related death. All LABA, including Arcapta Neohaler, should not be used in patients with asthma, unless used with a long-term asthma control medication.

The FDA approved Arcapta Neohaler with a medication guide that includes instructions for use and information about the potential risks of taking the drug. The most common side effects reported by those using Arcapta Neohaler include runny nose, cough, sore throat, headache and nausea.  

Arcapta Neohaler is marketed by Novartis Pharmaceuticals Corp. of East Hanover, N.J.

For more information:

National Heart, Lung, and Blood Institute: Chronic Obstructive Pulmonary Disease
http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_WhatIs.html

Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves XARELTO® (rivaroxaban tablets) to Help Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery
2. FDA Approves Lazanda® - First Fentanyl Nasal Spray - for the Management of Breakthrough Pain in Cancer Patients
3. FDA Approves First Generic Versions of the Antibiotic Levofloxacin to Treat Certain Infections
4. FDA Approves Nulojix for Kidney Transplant Patients
5. FDA Approves New Test To Help Determine if Breast Cancer Patients Are Candidates for Herceptin Treatment
6. FDA Approves First Ceramic-on-Metal Total Hip Replacement System
7. FDA Approves Redesigned Labels for Some Merck Drugs
8. FDA Approves Updates to Lillys Humalog® (insulin lispro injection [rDNA origin]) Label
9. FDA Approves Marketing of RMS Subcutaneous Needle Sets
10. FDA Approves Injectable Gel to Treat Fecal Incontinence
11. FDA approves Incivek for hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... , Oct. 10, 2017  NDS received FDA 510(k) clearance ... a medical-grade battery-powered display stand specifically designed for endoscopy environments. An ... technology into a clinical solution to support the improvement of patient ... Innovative Design ... Wireless Solution ...
(Date:10/4/2017)... the Centers for Disease Control and Prevention (CDC), influenza vaccination should ... helping communities across Massachusetts , Connecticut ... shots through the end of the month. *Some exclusions apply ... ... is by the end of October, according to the Centers for Disease ...
(Date:10/2/2017)... Halo Labs announces the European launch of their new low volume, ... 2017 in Cambridge, U.K on October 4th. ... samples with unprecedented speed and sensitivity while using far less sample ... ... system ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ... that offers insurance and financial preparation services, is providing an update on a ... organization. , Rock City Rescue is a locally recognized nonprofit that provides shelter ...
(Date:10/13/2017)... ... 13, 2017 , ... PurhealthRX , a leading Health and Nutrition Company, ... Purzorb™process to full spectrum CBD oil will revolutionize the rapidly growing CBD market by ... be easily incorporated into liquid products, while reducing costs to end users. , The ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... The Visiting ... Day Market. Featuring a collection of specialty vendors and unique items from across the ... and quality-focused health and wellness services offered by the VNA. The boutique will ...
(Date:10/13/2017)... , ... October 13, 2017 , ... ... and Agile Software Development, has been awarded a contract by the Center for ... Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies in a ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the ... today its plans to open a flagship location in Covington, LA at 401 N. ... To Go store next to Office Depot in the Holiday Square shopping center. Its ...
Breaking Medicine News(10 mins):