Navigation Links
FDA Approves ZYFLO CR(TM) (Zileuton) for Chronic Treatment of Asthma

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., for ZYFLO CR(TM) (zileuton) extended-release tablets. ZYFLO CR(TM) 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(TM).

ZYFLO CR(TM) and ZYFLO(R) (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(TM) and ZYFLO(R) 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(TM) uses SkyePharma PLC's (LSE: SKP) proprietary Geomatrix(R) drug delivery technology, which controls the amount and rate of drug released into the body.

"We applaud our marketing partner's 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(TM) 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(TM), which will continue to expand DEY's presence in asthma and respiratory care."

In March 2007, Critical Therapeutics and DEY entered into an agreement for the co-promotion of ZYFLO CR(TM) and ZYFLO(R), the immediate-release formulation of zileuton. DEY's sales force began promoting ZYFLO(R) on April 30, 2007. Upon the launch of ZYFLO CR(TM), the combined sales forces of the two companies will begin promoting ZYFLO CR(TM) to approximately 15,000 allergists, pulmonologists and primary care physicians across the U.S.


'"/>




Related medicine news :

1. FDA Approves Contraceptive Ring
2. FDA Approves New HIV Drug, Viread
3. FDA Approves Birth Control Skin Patch
4. FDA Approves New Arthritis Drug, Bextra
5. FDA Approves Elidel Cream for Eczema
6. FDA Approves New Anti-Clotting Drug
7. FDA Approves New surgery Treatment for Farsightedness
8. FDA Approves Anti-Cancer Cell Drug - Zevalin
9. FDA Approves Remodulin for Pulmonary Hypertension
10. World Health Organisation Takes a Historic Decision and Approves Treaty to Discourage Smoking
11. World Health Organisation Takes a Historic Decision and Approves Treaty to Discourage Smoking
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:3/22/2017)... (PRWEB) , ... March 22, 2017 , ... Old School ... boxing champ Ashley Theophane as a new Brand Ambassador. Theophane, who trained with Floyd ... welterweight title in 2011. He has racked up an impressive number of wins in ...
(Date:3/22/2017)... (PRWEB) , ... March 22, 2017 , ... ... solution provider, today announced that its digital marketing solutions have enabled Children’s Hospital ... investment in 24 months. , Recognizing the value of a digital marketing ...
(Date:3/22/2017)... ... March 22, 2017 , ... ... into a research collaboration to translate advances in basic neuroscience at the BMRI ... and beyond. The collaboration seeks to improve movement, vision, and cognition impaired by stroke, ...
(Date:3/22/2017)... Norwich, NY (PRWEB) , ... March 22, 2017 , ... ... to communities in the greater Nassau County region, is embarking on a combined charity ... breast cancer. , For the last 25 years, the Great Neck Breast Cancer ...
(Date:3/22/2017)... NC (PRWEB) , ... March 22, 2017 , ... Chris ... assistance to families and business professionals throughout the coastal plains region, is initiating a ... to overcome cancer. , Dillyn was first diagnosed with leukemia on a Friday evening ...
Breaking Medicine News(10 mins):
(Date:3/22/2017)... -- Kalorama Information has noted five news developments in ... industry.  This month the FDA granted a CLIA waiver to ... market has reached $18.4 billion in sales and continues ... battle and the acquisition by Abbott is still in ... chemistry analyzer and researchers evaluated fetal fibronectin screening for ...
(Date:3/22/2017)... , March 22, 2017 NetworkNewsWire Editorial ... ... given differing statements by White House officials. Federal laws are ... marijuana for medical and/or recreational use, and businesses like SinglePoint, ... Inc. (NASDAQ: CRBP), Medical Marijuana, Inc. (OTC: MJNA), Cannabis Science, ...
(Date:3/22/2017)... March 22, 2017  Based on its recent ... & Sullivan recognizes GE Healthcare with the 2016 ... Award. GE Healthcare,s strategy of innovating and expanding ... allowed it to effectively compete in a mature, ... In addition to aiding patient and clinician workflows, ...
Breaking Medicine Technology: