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:
(Date:3/28/2015)... NV (PRWEB) March 28, 2015 One ... re-injury, according to research presented today at the American ... Day. The study examined the long term success of ... , “We examined survey data from 242 patients who ... author Justin P. Roe, MBBS, FRACS, from North Sydney ...
(Date:3/28/2015)... 2015 Early surgery may not be ... AC joint injuries, according to new research from Tripler ... American Orthopaedic Society for Sports Medicine’s ( AOSSM ) ... when surgery was not performed. , The final study ... treatment and 17 receiving non-surgical therapy. Of the non-surgery ...
(Date:3/28/2015)... 2015 Lately the student-athlete experience ... changes and proposals around the NCAA. In a March ... collegiate student-athletes across a spectrum of universities and sports ... challenges. The special panel consists of athletes who have ... from football, track and field, baseball, and volleyball. They ...
(Date:3/28/2015)... Vegas, NV (PRWEB) March 28, 2015 ... groundbreaking new method of sustainable health. After 18 years ... of life, including professional UFC contenders, Dr. Jon Petrick ... this summer. , Just some of the immediate benefits ... energy and vitality, increased levels of strength of the ...
(Date:3/28/2015)... Plainview, NY (PRWEB) March 28, 2015 ... provider of dietary supplements announces the release of ... MuffinStop™ was shown in two randomized, double-blind, placebo-controlled ... weight and waist and hip size. MuffinStop™ is ... Sphaeranthus indicus and Garcinia mangostana, fused together to ...
Breaking Medicine News(10 mins):Health News:Young Athletes at Greater Risk for Re-Injury after ACL Surgery 2Health News:For Type V AC Joint Injuries, Early Surgery May Not Be the Best Approach 2Health News:SCI TV Panel of Former College Athletes Discusses Student Athlete Experience 2Health News:SCI TV Panel of Former College Athletes Discusses Student Athlete Experience 3Health News:Celebrity Chiropractor Jon Petrick to Release Sustainable Health System this Summer 2Health News:Purity Products Releases Revolutionary New Weight Loss Product, MuffinStop™ 2
(Date:3/27/2015)... , March 27, 2015 Levi & Korsinsky ... Inc. (NASDAQ: OHRP ) concerning possible violations of ... by the Company in connection with its study of ... http://zlk.9nl.com/ohr-pharmaceutical-ohrp or contact Joseph E. Levi, ... or by telephone at (212) 363-7500, toll-free: (877) 363-5972. ...
(Date:3/27/2015)... Dynatronics Corporation (NASDAQ: DYNT ) today announced ... the Company,s Board of Directors effective March 23, 2015, to ... of board member Joseph Barton .  ... of Directors represents an important step forward for the company," ... Dynatronics.  "Rich is a proven leader and is well-known for ...
(Date:3/27/2015)... -- Biopharmaceutical Industry Leads Manufacturing Sector in R&D ... top as the country,s manufacturing leader in innovation and ... According to the  analysis , the industry had the ... decade, accounting for 27 percent of average annual R&D ... Video on Medicare Part D - Medicare Part ...
Breaking Medicine Technology:Dynatronics Announces Appointment of Richard J. Linder to Board of Directors 2Week in Review: The Latest from PhRMA 2
Cached News: