Navigation Links
FDA Advisory Committee Recommends Approval for Boehringer Ingelheim's Olodaterol for Maintenance Treatment of COPD
Date:1/29/2013

RIDGEFIELD, Conn., Jan. 29, 2013 /PRNewswire/ -- Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended that clinical data included in a new drug application (NDA) provide substantial and convincing evidence to support the approval of olodaterol as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. If approved by the FDA, it is anticipated that olodaterol will be marketed under the brand name Striverdi Respimat in the United States.

"We at Boehringer Ingelheim are pleased with the Advisory Committee's recommendation and look forward to continuing to work with the FDA as the Agency continues its review of the olodaterol NDA," said Tunde Otulana , MD, vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc.  "The positive vote from the Advisory Committee marks an important step towards making olodaterol available to the approximately 24 million patients with COPD in the United States."

The Committee also voted affirmatively that data showed the efficacy and safety of olodaterol supports approval of the 5 microgram dose. 

The Committee reviewed data from the Phase 3 olodaterol clinical trial program, including data from the 48-week and 6-week duration trials. These data are part of the NDA being reviewed to establish that olodaterol delivered once daily at the 5 microgram dose showed improvements in lung function, as measured by forced expiratory volume in one second (FEV1), in patients with moderate to very severe COPD compared to placebo and also active comparators.

The trials were conducted in a patient population represent
'/>"/>

SOURCE Boehringer Ingelheim
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. HeartWare Stock Trading Halted Today; FDA Advisory Committee to Review HeartWare® Ventricular Assist System as a Bridge to Heart Transplantation
2. Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
3. Regeneron Provides Update On FDA Advisory Committee Discussion of ARCALYST® (rilonacept) Injection
4. Generex Announces New Members of Antigen Express Scientific Advisory Board for the AE37 Breast Cancer Vaccine
5. Generex Augments Antigen Express Scientific Advisory Board
6. IntelliCell Announces Dr. Arnold I. Caplan Joins Scientific Advisory Board
7. Generex Reports on Inaugural AE37 Breast Cancer Vaccine Scientific Advisory Board Meeting
8. Marken Announces Global Advisory Board
9. Obesity journal publishes new study on lorcaserin, a weight-loss medication recommended for approval by FDA advisory panel
10. Detroit Metro Convention & Visitors Bureau announces launch of Medical Meetings Initiative; recruits top leaders to Advisory Council
11. Oncos Therapeutics Announces Clinical Advisory Board for its Oncolytic Virus and Cancer Immunotherapy Development Programs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2015)...  Amgen (NASDAQ: AMGN ) today announced ... Key results include: , Total revenues increased ... to $5,370 million, with 6 percent product sales ... Prolia ® (denosumab), Sensipar ® (cinacalcet), ... (denosumab). Unfavorable changes in foreign exchange rates impacted ...
(Date:7/30/2015)... WOODCLIFF LAKE, N.J. , July 30, 2015 /PRNewswire/ ... submitted simultaneously in the United States ... (to the FDA, EMA and MHLW, respectively) for eribulin, ... sarcoma (STS) who have received prior chemotherapy for advanced ... are based on data from a pivotal global Phase ...
(Date:7/30/2015)... Japan , July 30, 2015 ... of the study to fulfill the post-marketing commitment ... the Pan European Multi-Database Bladder Cancer Risk ... retrospective matched cohort study, conducted in four European ... HCI) with up to 10 years of follow-up. ...
Breaking Medicine Technology:Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 2Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 3Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 4Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 5Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 6Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 7Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 8Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 9Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 10Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 11Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 12Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 13Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 14Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 15Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 16Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 17Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 18Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 19Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 20Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 21Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 22Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 23Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 2Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 3Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 4Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 5Takeda Announces Completion of the Pioglitazone Post-Marketing Commitment and Submission of Results to the EMA, the FDA and the PMDA 2Takeda Announces Completion of the Pioglitazone Post-Marketing Commitment and Submission of Results to the EMA, the FDA and the PMDA 3Takeda Announces Completion of the Pioglitazone Post-Marketing Commitment and Submission of Results to the EMA, the FDA and the PMDA 4Takeda Announces Completion of the Pioglitazone Post-Marketing Commitment and Submission of Results to the EMA, the FDA and the PMDA 5Takeda Announces Completion of the Pioglitazone Post-Marketing Commitment and Submission of Results to the EMA, the FDA and the PMDA 6
... Calif. , June 14 The ... directly to cancer sites with minimal exposure to ... multiple publications, according to Xoft, Inc., developer of ... provider of FDA-cleared Electronic Brachytherapy Systems, Xoft provides ...
... of the Pros & Cons of Robotic Surgery , ... PHILADELPHIA , June 11 Robotic surgery -- is it ... campaigns and targeted marketing to physicians? , , ... robots help surgeons perform surgery with greater access, visibility and precision all which reduce ...
Cached Medicine Technology:Clinical Benefits of Electronic Brachytherapy From Xoft Substantiated for the Treatment of Multiple Cancers 2Clinical Benefits of Electronic Brachytherapy From Xoft Substantiated for the Treatment of Multiple Cancers 3Clinical Benefits of Electronic Brachytherapy From Xoft Substantiated for the Treatment of Multiple Cancers 4Robotic Surgery: Medicine or Marketing? 2Robotic Surgery: Medicine or Marketing? 3Robotic Surgery: Medicine or Marketing? 4Robotic Surgery: Medicine or Marketing? 5
(Date:7/30/2015)... ... July 30, 2015 , ... As more hospitals across the country see ... becomes a serious challenge. Because of growing competition, it is more important than ... community. , The team at Wound Care Advantage has found that ...
(Date:7/30/2015)... ... July 30, 2015 , ... The connection between a healthy head of hair and ... loss of a full head of hair can have a devastating impact on the daily ... perceived in the work place, the consequences of hair loss are not to be taken ...
(Date:7/30/2015)... (PRWEB) , ... July 30, 2015 , ... ... TikiLIVE, has worked to protect victims in San Diego, California’s Gaslamp Quarter Plaza ... used by Gaslamp Quarter Plaza actively monitor the area for any suspicious activity. ...
(Date:7/30/2015)... San Diego, CA (PRWEB) , ... July 30, ... ... company has been consistently growing into one of the largest, family-owned low cost ... offered across residential and commercial applications, as well as growing their company to ...
(Date:7/30/2015)... ... July 30, 2015 , ... ... its position as one of Medicare’s top-rated care centers. The video highlights ... CMS rating system, which monitors health inspections, staffing, and quality measures. Beachside ...
Breaking Medicine News(10 mins):Health News:WCA Offers Shockwave; The Marketing Module for Hospital Wound Care Programs 2Health News:WCA Offers Shockwave; The Marketing Module for Hospital Wound Care Programs 3Health News:WCA Offers Shockwave; The Marketing Module for Hospital Wound Care Programs 4Health News:New Study Shows the Link between Hair Restoration and Healthy Self-Image 2Health News:Eyepartner Software Helps Victims in Gaslamp Quarter Plaza 2Health News:Eyepartner Software Helps Victims in Gaslamp Quarter Plaza 3Health News:Bill Howe Plumbing, Heating & Air Launches Online Application to Prospective Employees 2Health News:Bill Howe Plumbing, Heating & Air Launches Online Application to Prospective Employees 3Health News:Beachside Nursing Center Releases New Video 2
... Aiming to increase its presence in the Indian market and ... to add a punch of health// to its India portfolio, ... at offering total beverage solutions in the non-alcohol segment. This ... health-based products,’ Coca Cola India chief Atul Singh told PTI ...
... Washington – Dutch research into child cancer survivors has revealed ... are twice as much compared// to those without a history ... survivors, those that have survived brain cancer or other central ... of remaining jobless. The Children, who came out of blood-cell ...
... children who are exposed to cats soon after birth face ... causes the skin// to become red, scaly and itchy. This ... on May 21st. , ,Being exposed to two ... not significant, effect on children's risk of developing eczema, said ...
... have announced that, they are taking preventive steps with as ... past three months//. ,A senior health official ... visit Tripura to assess the situation and to provide expert ... also stated that almost 200 teams, consisting of health workers ...
... doctors of Sir Sunderlal hospital in the Banaras Hindu University ... day today to protest against the proposed 27 per cent ... ,Apart from the relay hunger strike, the agitating ... out mass mobilisation campaign on the issue at the Assi ...
... one study it was said that 44 % of women ... affects both the mental health as well as the physical ... senior investigators of the Group Health Center for Health Studies, ... researchers found that nearly half -44 per cent, reported having ...
Cached Medicine News:Health News:Children Having An Early Exposure To Cats May Develop Eczema 2
... Continuing a tradition of progressive centrifuge ... CL3 series. The Centra-CL3 and Centra-CL3R (refrigerated) ... todays laboratory., Quality Control Over Sample ... and lock up to 99 protocols and ...
Inquire...
... Rotor has a standard 1.5ml rotor and 6 ... Easy operation (no switches to mess with). Simply ... the plastic tab to open. Starts and stops ... 2000 x g. Only five inches in diameter. ...
Inquire...
Medicine Products: