Navigation Links
FDA Grants Bayer HealthCare Pharmaceuticals Orphan Drug Designation for Investigational Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis
Date:3/11/2010

FDA for the designated orphan drug and applies only to the indication for which the drug has been designated and approved.  The approval of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and efficacy of a compound must be established through adequate and well-controlled studies.

About Bayer HealthCare Pharmaceuticals

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Forward-Looking Statements

This release ma
'/>"/>

SOURCE Bayer HealthCare Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Debiopharm Group Grants an Exclusive Licence for the Development, Manufacture and Commercialisation of Debio 025
2. Hospira Supports Disaster Relief Efforts in Haiti With Products and Cash Grants
3. Chiasma Grants Option to License Transient Permeability Enhancer (TPE) Technology for Small Molecule Products
4. Orexigen(R) Therapeutics Reports Inducement Grants Under NASDAQ Listing Rule 5635
5. European Medicines Agency Grants Cell Therapeutics Orphan Drug Designation for Pixantrone in Diffuse Large B-Cell Lymphoma (DLBCL)
6. Pfenex Grants Exclusive License to Merck & Co., Inc. for the Production of Proteins for Undisclosed Vaccine Program
7. FDA Grants Cequent IND - Clears Way for First-Ever Clinical Trial of Orally Delivered RNAi Therapeutic: CEQ508, a tkRNAi Drug Candidate in Oncology
8. SRI International Receives National Institutes of Health Grants to Develop Improved Tomographic Imaging Technology
9. The Epilepsy Research Foundation and Milken Family Foundation Announce Prestigious Translational Research Grants for Two Pioneering Epilepsy Therapies
10. U.S. Food And Drug Administration (FDA) Grants Traditional Approval for INTELENCE(R) (etravirine)
11. FDA Grants GeoVax Labs, Inc. Request For Pre-IND Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... 2014   Decision Resources Group finds that ... chronic kidney disease non-dialysis (CKD-ND) patients are not ... In addition, one-year persistency is similar between Amgen,s ... key findings from the report entitled ... Stimulating Agents in Late Stage Chronic Kidney Disease ...
(Date:9/30/2014)... Ind. , Sept. 30, 2014  The orthopedic specialists ... the nation,s No. 6 orthopedic group by US News ... Active Adults," a series of free, public seminars to ... all over the world come to see the knee ... procedures are now available at Munster Specialty Surgery Center. ...
(Date:9/30/2014)... In 2011, approximately 5.1 million people in ... pain relievers (e.g. opioids). 1 Clinical treatments for ... the use of buprenorphine, buprenorphine/naloxone, naltrexone or methadone. The ... developing and improving care management programs, according to ... Therapeutics LLC (Prime). Cost trends ...
Breaking Medicine Technology:Persistency is Low for Late-Stage Anemic CKD Non-Dialysis Patients Treated with Erythropoiesis-Stimulating Agents 2Persistency is Low for Late-Stage Anemic CKD Non-Dialysis Patients Treated with Erythropoiesis-Stimulating Agents 3"Knee Pain Solutions for Active Adults" Complimentary Seminars Open to the Public 2Studies show cost and use of opioid dependence treatment are increasing, spurring the need for care management programs 2Studies show cost and use of opioid dependence treatment are increasing, spurring the need for care management programs 3
... , LITTLE FALLS, N.J., Dec. 2 ... the results for its first quarter ended October 31, 2009 on ... to discuss the results at 11:00 AM ET. Participating in ... President and CEO; Seth R. Segel, Executive Vice President; Craig A. ...
... , , CENTENNIAL, Colo., Dec. 2 ... bone and soft tissue allografts for use in surgical procedures ... substitutes, today announced its sponsorship of a truly iconic symbol ... Life float in the January 1, 2010 Tournament of Roses ...
Cached Medicine Technology:Cantel Medical Corp. to Hold Conference Call to Discuss Results for its First Quarter Ended October 31, 2009 2AlloSource Sponsors Heroic Quadruple Amputee as Rider Aboard 2010 Donate Life Rose Parade Float 2AlloSource Sponsors Heroic Quadruple Amputee as Rider Aboard 2010 Donate Life Rose Parade Float 3
(Date:9/30/2014)... NJ (PRWEB) September 30, 2014 ... and wellness, is opening another new medical specialty practice ... IMA Cardiology will be located within the ... Ziad Abbud and Dr. Isaac Tawfik of American Heart ... N.J. The new practice will offer Integrated Medicine Alliance ...
(Date:9/30/2014)... Las Vegas, NV (PRWEB) September 30, 2014 ... released by Blue Star Nutraceuticals designed to help maximize ... ingredients that optimizes the body’s absorption of glucose has ... review. , “The main purpose behind Glycodrive is ... that builds lean muscle,” reports Michaels. “Carbs are essential ...
(Date:9/30/2014)... Los Angeles, CA (PRWEB) September 30, 2014 ... plastic surgery providers in Turkey has gone up more ... of growth. The medical tourism company also reported total ... since October 2012. , The company’s professional strategy has ... in Turkey — ultimately designed for patient comfort and ...
(Date:9/30/2014)... Washington, DC (PRWEB) September 30, 2014 A ... the world to combat an epidemic that, left unchecked, could ... no, they are not headed to Africa. John Rogers, the ... headed to North Korea to fight a disease most think ... the US some 80 years ago is on the comeback ...
(Date:9/30/2014)... 2014) Levothyroxine is considered the gold standard therapy ... review of therapies for the condition including combining ... assessment, say a team of investigators.,1Their analysis, published as ... , finds insufficient consistent data exist to recommend a ... sold under various trade names, such as Synthroid ...
Breaking Medicine News(10 mins):Health News:Integrated Medicine Alliance Announces New Cardiology Practice 2Health News:Glycodrive Review Exposes Blue Star Nutraceutical’s Supplement for Leaner, Stronger Muscles 2Health News:VisitandCare.com Announces Record Demand for Plastic Surgery in Turkey 2Health News:VisitandCare.com Announces Record Demand for Plastic Surgery in Turkey 3Health News:VisitandCare.com Announces Record Demand for Plastic Surgery in Turkey 4Health News:US Delegation Heads to North Korea to Combat Tuberculosis Epidemic 2Health News:New guidelines for treatment of hypothyroidism endorse current therapy 2
... EDITOR,S PICK: At-TRIB(1)-uting a gene a new function in the ... region of human chromosome 8 have recently been linked to ... risk of atherosclerosis (a disease of the major arterial blood ... stroke). The only currently described gene in this region of ...
... the primary care team right in doctors, offices may ... manage associated risks, a new University of Alberta study ... Type 2 diabetes dropped significantly when pharmacists were included ... U of A study showed. Among 153 patients whose ...
... -- People who started smoking marijuana at a young age ... those who started smoking when they were older, a new ... marijuana and the need to develop effective strategies to reduce ... noted that adolescence is a critical time in brain development. ...
... (HealthDay News) -- People who wear multifocal contact lenses have ... a new study finds. Multifocal lenses correct near vision ... This study included 11 volunteers, aged 45 to 64, ... Wearing multifocal contact lenses resulted in significantly slower ...
... � Following the Plenary Session of the 2010 ... (PSWC) in association with the American Association of ... Danny D. Shen, Ph.D. presented the following ground-breaking ... pharmaceutical sciences: AAPS Presidential Citation , ...
... procedure, using a robotic arm alongside 3-D mapping, is due ... It comes six months after Dr Andre Ng carried out ... Robotic Catheter System. Dr Ng, is senior lecturer ... at Glenfield Hospital. On Tuesday 16 November, Dr ...
Cached Medicine News:Health News:JCI online early table of contents: Nov. 15, 2010 2Health News:JCI online early table of contents: Nov. 15, 2010 3Health News:JCI online early table of contents: Nov. 15, 2010 4Health News:JCI online early table of contents: Nov. 15, 2010 5Health News:JCI online early table of contents: Nov. 15, 2010 6Health News:Early 'Pot' Use May Harm Brain More: Study 2Health News:AAPS presents awards to exemplary researchers 2Health News:AAPS presents awards to exemplary researchers 3Health News:AAPS presents awards to exemplary researchers 4Health News:Robo-op marks new world first for heart procedure 2
The fat loss formula's key ingredient of 2.0% aminophylline works by penetrating deep into the skin where it causes the body fat cells to shrink, resulting in up to 2 inches of body fat loss....
... VelaSmooth is the first ... device with the revolutionary elos ... Radio Frequency and Infrared Light ... with suction to reduce the ...
... was designed with the physician, staff ... you the best economy exam room ... does not skimp on patient comfort. ... can easily position patients so that ...
The Salt A-Peel™ microdermabrasion combines, positive air pressure, pure salt, ultrasound and the application of rich anti oxidant products to deliver a remarkable 'The Salt A-Peel' anti ageing...
Medicine Products: