HOME >> MEDICINE >> NEWS
FDA approves Dey, L.P.'s Perforomist inhalation solution for maintenance treatment of COPD

Napa, CA (May 11, 2007) Dey, L.P. announced today that the Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Perforomist (formoterol fumarate) Inhalation Solution for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).

Formoterol is a rapid and long-lasting beta2 agonist that has been previously approved in the U.S. as a dry powder formulation, and the molecule has twenty years of worldwide use. Perforomist Inhalation Solution is the first and only FDA-approved nebulized formoterol fumarate. Nebulizers convert liquid medication into a mist that patients inhale through a mouthpiece or face mask.

"The first nebulized formoterol fumarate, Perforomist Inhalation Solution offers a new treatment option to COPD patients," said Nicholas J. Gross, MD, PhD, Principal Investigator of the Phase III pivotal clinical trial and an expert on lung diseases, particularly COPD. "By nebulizing with Perforomist Inhalation Solution twice a day once in the morning and once in the evening many COPD patients can achieve better control of their disease symptoms. The convenience of such simple dosing combined with a drug delivery option favored by many patients may provide improved symptom control and a better quality of life for the millions of Americans who live with COPD."

Mel Engle, President and CEO at DEY, noted, "As the US leader in nebulized respiratory products, we are thrilled to bring Perforomist Inhalation Solution, a new patented treatment option for COPD patients, to the market. Nebulization is a time tested and reliable drug delivery option. DEY has a long history of developing and marketing innovative respiratory therapeutics. The approval of Perforomist Inhalation Solution fits perfectly with our overall strategy for respiratory medications."

Gene L. Colice, MD, Department
'"/>

Contact: Harriet Ullman
harriet.ullman@fkhealth.com
617-761-6776
Feinstein Kean Healthcare
11-May-2007


Page: 1 2

Related medicine news :

1. DFG approves 11 new Collaborative Research Centers
2. FDA approves ZYFLO CR extended-release tablets for chronic treatment of asthma
3. VCR -- FDA approves home discharge for US patients
4. FDA approves prescription Zaditor for over-the-counter relief from itchy eyes
5. FDA approves Vectibix to treat patients with metastatic colorectal cancer
6. 5,000 rare diseases need drugs, but Europe only approves a handful each year
7. FDA approves room temperature storage of ZLB Behrings Helixate FS
8. FDA approves new indication for Topamax as initial monotherapy for adults and children with epilepsy
9. FDA approves first blood test to predict risk for stroke
10. FDA approves Boostrix a new US vaccine for adolescents against pertussis
11. Clinical trial data for Perforomist Inhalation Solution presented at International ATS Conference

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:5/24/2016)... WI (PRWEB) , ... May 24, 2016 , ... ... announced that Rudolfo (Rudy) Cifolelli has joined the company as Vice President of ... the development of U.S. and international sales in the rapidly expanding field of ...
(Date:5/24/2016)... ... May 24, 2016 , ... Women's Excellence announces ... Jordan is a Certified Nurse Midwife who was born and raised in Michigan. ... on to complete her masters degree from the University of Mexico. Roberta is ...
(Date:5/24/2016)... ... 2016 , ... United Benefit Advisors (UBA), the nation’s leading ... & Co., Inc. Headquartered in Albany, New York, Austin & Co., Inc. ... and beyond. As an employee-owned company celebrating over 160 years of service, ...
(Date:5/24/2016)... , ... May 24, 2016 , ... ... Surgery Center at Sentara Northern Virginia Medical Center located in Woodbridge, VA. ... hospital’s surgical services into a single site. , The new 2 story building ...
(Date:5/24/2016)... ... May 24, 2016 , ... Mental health watchdog Citizens Commission on Human ... renowned professor of psychiatry Thomas Szasz, is continuing its protest against the use of ... exhibit in Atlanta, Georgia. The opening of the exhibit follows CCHR’s recent protest at ...
Breaking Medicine News(10 mins):
(Date:5/23/2016)... 23, 2016 Non-invasive diagnostic test ... multiple diseases; ,Technology to be presented at Yissum’s booth, ... Research Development Company of the Hebrew University of Jerusalem ... agreement with Aurum Ventures MKI, the technology investment arm of ... new diagnostic approach for early detection of multiple diseases ...
(Date:5/23/2016)... SAN FRANCISCO , May 23, 2016 ... expected to reach USD 5.0 billion by 2022, according ... The increasing generation of medical waste coupled with the ... healthcare industry is expected to drive the demand for ... with these devices as compared to that of the ...
(Date:5/20/2016)... 20, 2016 ReportsnReports.com adds ... Medical Devices of its online business intelligence library. ... the current state of the Titrator industry. The ... like definitions, classifications, Specifications, applications and industry chain ... like Raw Material Suppliers, Equipment Suppliers, Manufacturing Cost ...
Breaking Medicine Technology:
Cached News: