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ZYFLO in Medical News

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-p...

Cornerstone Therapeutics Submits Regulatory Filing for Extended-Release Antitussive Product

...cialize our products, including difficulties relating to the manufacture of zyflo CR((R)) tablets; the possibility that the Food and Drug Administration (the...resenting our views as of any date after the date of this release. zyflo CR((R)) is a registered trademark of Cornerstone Therapeutics Inc. Source(...

Cornerstone Therapeutics Joins the Russell 3000(R) Index

...cialize our products, including difficulties relating to the manufacture of zyflo CR(R) tablets; the possibility that the Food and Drug Administration (the F... representing our views as of any date after the date of this release. zyflo CR(R) is a trademark of Cornerstone Therapeutics Inc. Russell 3000 Index, ...

Asthma Drugs Get 'Precaution' Labeling for Possible Psychiatric Side Effects

... (montelukast), as well as Accolate (zafirlukast). zyflo and zyflo CR (zileuton), drugs in a class known as leukotrie...ed by the manufacturers of Singulair, Accolate and zyflo suggested the products are not associated with an ...

Cornerstone Therapeutics Announces Management Change

...cialize our products, including difficulties relating to the manufacture of zyflo CR(R) tablets; the possibility that the Food and Drug Administration (the F... representing our views as of any date after the date of this release. zyflo CR(R) is a trademark of Cornerstone Therapeutics Inc. Investor Re...

Cornerstone Therapeutics Reports First Quarter 2009 Financial Results

...sults of Critical Therapeutics (including sales of zyflo CR(R) and ZYFLO(R)) prior to the completion of the...launched in May 2008, and $5.3 million in sales of zyflo CR and ZYFLO. Gross profit was $27.5 milli...ase in co-promotion expenses primarily relating to zyflo CR. Royalty expenses were $6.3 million in the...

Cornerstone Therapeutics Announces $70 Million Strategic Transaction With Chiesi Farmaceutici SpA

...cialize our products, including difficulties relating to the manufacture of zyflo CR(R) tablets; the possibility that the FDA will take enforcement action ag...roxy statement relating to the transaction when it becomes available. zyflo CR(R) is a trademark of Cornerstone Therapeutics Inc. Curosurf(R) is a tra...

Cornerstone Therapeutics to Host First Quarter 2009 Conference Call

...alize our products, including difficulties relating to the manufacturing of zyflo CR(R) tablets; the possibility that the Food and Drug Administration (the F... representing our views as of any date after the date of this release. zyflo CR(R) is a trademark of Cornerstone Therapeutics Inc. Investor Re...

FDA Finds No Link So Far Between Asthma Drugs and Suicide Risk

...ir, top-selling drug for teens, plus Accolate and zyflo show no behavioral changes in trials submitted by ...ed by the manufacturers of Singulair, Accolate and zyflo suggest the products are not associated with an in...ted information showing no suicidal behavior among zyflo users. A Merck executive told the AP Tuesday ...

FDA Probing Possible Link Between Asthma Drug and Suicide Risk

...ted it was also looking into whether other related drugs, such as Accolate, zyflo and zyflo CR need to be investigated as well. "Due to the complexity of the analy...
ZYFLO in Medical Technology

Critical Therapeutics Announces the Publication of Data for ZyfloCR (Zileuton) Extended-Release Tablets in the Journal of Asthma

...of data from a pivotal Phase III clinical trial of zyflo CR(TM) (zileuton) extended-release tablets in the June 2007 issue of the Journal of Asthma. zyflo CR was approved by the U.S. Food and Drug Administ...artner Dey, L.P. (DEY), expects to begin marketing zyflo CR in the U.S. in the fall of 2007....
ZYFLO in Biological Technology

Dey L.P. and Critical Therapeutics Launch Twice-Daily ZYFLO CR(TM) (Zileuton) Extended-Release Tablets for the Chronic Treatment of Asthma

First twice-daily leukotriene synthesis inhibitor provides additional treatment option for asthma patients not fully controlled on other medications NAPA, Calif., Sept. 27 /PRNewswire-FirstCall/ -- Dey, L.P., an affiliate of Merck KGaA of Darmstadt, Germany, ann...

Cornerstone Therapeutics Announces Closing of Chiesi Transaction

...ional information regarding the interests of those persons may be obtained by reading the proxy statement relating to the proposed amendments. zyflo CR((R)) is a registered trademark of Cornerstone Therapeutics Inc. Curosurf((R)) is a trademark of Chiesi Farmaceutici SpA. Investor Rela...

Cornerstone Therapeutics Inc. Announces Record Date and Meeting Date for Special Meeting of Stockholders for Vote with Respect to Charter Amendments

...cialize our products, including difficulties relating to the manufacture of zyflo CR(R) tablets; the possibility that the Food and Drug Administration (the F... representing our views as of any date after the date of this release. zyflo CR(R) is a trademark of Cornerstone Therapeutics Inc. ...

Cornerstone Therapeutics Reports Year Ended December 31, 2008 Financial Results

...sults of Critical Therapeutics (including sales of zyflo CR(R) and ZYFLO(R)) prior to the completion of the...ax(R) line of products, and two months of sales of zyflo CR and zyflo after the closing of the merger totaling $888,000....

Cornerstone Therapeutics to Host Quarter and Year Ended December 31, 2008 Conference Call

...keting, supply chain, distribution and manufacturing capabilities to commercialize our products, including difficulties relating to the manufacture of zyflo CR(R); our reliance on products marketed under Food and Drug Administration, or FDA; enforcement policies established in connection with the FDA's Dru...

Cornerstone Therapeutics Provides Update on Integration Activities and Issues 2008 Revenue Guidance

...the fourth quarter. The Company anticipates 2008 net revenues to be in excess of $64 million, which will include revenues attributable to ZYFLO(R) and zyflo CR(R) only for the months of November and December. "We have completed the process of combining the operations of the two companies," said ...
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