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:10/13/2017)... ... 2017 , ... The Visiting Nurse Association (VNA) of Somerset Hills is proud ... and unique items from across the nation, this holiday-themed event will raise funds and ... the VNA. The boutique will be open Saturday, November 4 (10:00 a.m. – ...
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids this ... by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited about ... ages; it is a non-competitive, non-timed event, which is all about having fun and ...
(Date:10/13/2017)... ... 2017 , ... Talented host, actor Rob Lowe, is introducing ... new episode of "Success Files," which is an award-winning educational program broadcasted on ... subject in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “The Journey: ... faced every danger possible to save lost souls in the Philippines. “The Journey: From ... Carole is a dedicated teacher of the Bible. She has taught all ages and ...
(Date:10/12/2017)... Del. (PRWEB) , ... October 12, 2017 , ... ... and advisory services for healthcare compliance program management, will showcase a range of ... National Association for Assisted Living (NCAL) Convention and Expo to be held October ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... 2017 Diplomat Pharmacy, Inc. (NYSE: ... Consulting, LLC , and named its founder as Diplomat,s ... Tennessee , will operate under Diplomat ... service offerings for health care partners to include IT ... "In an interoperable world, technology delivers comprehensive ...
(Date:9/28/2017)... Hill-Rom Holdings, Inc. (NYSE: HRC), will host its fiscal ... Friday, November 3, 2017, beginning at 7:00 a.m. (CDT) ... a.m. (CDT) / 9:30 a.m. (EDT). In ... guidance for 2018, Hill-Rom executives will also highlight the ... long-range financial outlook through 2020. ...
(Date:9/25/2017)... PROVIDENCE, R.I. , Sept. 25, 2017 /PRNewswire/ ... immunogenicity assessment, vaccine design, and immune-engineering today announced ... focused on the development of personalized therapeutic cancer ... and has provided exclusive access to enabling technologies ... MSc Eng., MBA will lead EpiVax Oncology as ...
Breaking Medicine Technology:
Cached News: