HOME >> MEDICINE >> NEWS
FDA approves ZYFLO CR extended-release tablets for chronic treatment of asthma

Napa, CA (May 31, 2007) Dey, L.P. announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) of its marketing partner, Critical Therapeutics, Inc. (Nasdaq: CRTX), for ZYFLO CR (zileuton) extended-release tablets. ZYFLO CR offers twice-daily, extended-release dosing. Under a co-promotion agreement executed between the two companies in March 2007, DEY will co-market Critical Therapeutics ZYFLO CR.

ZYFLO CR and ZYFLO (zileuton tablets) are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO CR and ZYFLO are not indicated for use in the reversal of bronchospasm in acute asthma attacks, but can be continued during acute exacerbations of asthma. Leukotrienes are inflammatory mediators in asthma that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion. ZYFLO CR uses SkyePharma PLCs (LSE: SKP) proprietary Geomatrix drug delivery technology, which controls the amount and rate of drug released into the body.

We applaud our marketing partners success in securing FDA approval of the only twice-daily leukotriene synthesis inhibitor for asthma, said Mel Engle, President and CEO of DEY. ZYFLO CR has a unique mechanism of action that, combined with its twice-daily dosing regimen, could fundamentally expand and improve the treatment options available to asthma patients. We are delighted to participate in commercializing Critical Therapeutics ZYFLO CR, which will continue to expand DEYs presence in asthma and respiratory care.

In March 2007, Critical Therapeutics and DEY entered into an agreement for the co-promotion of ZYFLO CR and ZYFLO, the immediate-release formulation of zileuton. DEYs sales force began promoting ZYFLO on April 30, 2007. Upon the launch of ZYFLO CR, the combined sales forces of the two companies will begin prom
'"/>

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


Page: 1 2

Related medicine news :

1. DFG approves 11 new Collaborative Research Centers
2. FDA approves Dey, L.P.s Perforomist inhalation solution for maintenance treatment of COPD
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. Takeda submits new drug application for extended-release type 2 diabetes medication, ACTOplus met

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


(Date:12/2/2019)... ... December 02, 2019 , ... Interim HealthCare Inc. , a national ... 2019 Workforce: Optimas Awards . Selected for its multi-pronged approach to building a ... combat the nation’s caregiver shortage. By 2025, the U.S. will need to hire 2.5 ...
(Date:11/30/2019)... ... November 29, 2019 , ... ... honored customs, teachers aren’t focusing on the potential for academic backslide but rather ... up their textbooks or logging into GoogleClassroom as often during the break but ...
(Date:11/27/2019)... ... November 27, 2019 , ... AltMed Florida , one of ... has announced the grand opening of its newest MÜV™ Medical Cannabis Dispensary at 10 ... , AltMed’s eleventh MÜV Dispensary in Florida, is located on the corner of North ...
(Date:11/23/2019)... ... ... AIS Network has been selected as an award winner in ... fall — recognizes the world’s best digital health resources. , The Northern Virginia ... Web-Based Digital Health/Responsive Website Design. , “We were delighted to participate in ...
(Date:11/22/2019)... ... November 22, 2019 , ... Sepsis Alliance, ... of medical imaging, monitoring, biomanufacturing, and cell and gene therapy technologies, today announced ... of this relationship, GE Healthcare is sponsoring the webinar series, Can We Help ...
Breaking Medicine News(10 mins):
(Date:11/23/2019)... ... November 22, 2019 , ... For the third year ... of the annual USGBC Greenbuild conference and expo in addition to showcasing a test ... of the company’s Patcraft, Shaw Contract and Shaw Floors Builder Group brands. , Shaw ...
(Date:11/23/2019)... (PRWEB) , ... November 23, 2019 , ... ... -- the number of birthdays we’ve celebrated -- has also broadly served as ... age isn’t the best way to make those assessments? , Researchers at the ...
(Date:11/22/2019)... ... 22, 2019 , ... Experienced dentist, Dr. Kevin Hogan, has ... three-year program enhances Dr. Hogan’s expertise on the placement and restoration of dental ... The Misch International Implant Institute has offered leading dental implant training ...
Breaking Medicine Technology:
Cached News: