AccessMyLibrary provides FREE access to over 30 million articles from top publications available through your library.
Create a link to this page
Copy and paste this link tag into your Web page or blog:
Pharma Developments.
Pharma Developments
Panel OKs Kynapid, votes down Pulzium
CDU Staff Report
An FDA panel recently recommended approval of Kynapid but rejected giving a recommendation to Pulzium to treat atrial fibrillation (AF), a condition in which panel of federal advisers this week told the FDA that it should approve Kynapid and Pulzium to treat atrial fibrillation (AF).
Kynapid (vernakalant) is being co-developed by Cardiome Pharma (Vancouver) and Astellas Pharma U.S. (Deerfield, Illinois). Cardiome granted exclusive licensing rights to the U.S. affiliate of Astellas (Tokyo) in October 2003 to develop and commercialize Kynapid in North America. ...
- FDA Panel OKs Kynapid, But Votes Against Pulzium.
- Magazine article from: BIOWORLD Today Young, Donna December 13, 2007 700+ words
...federal advisers told the FDA that it should approve Kynapid but reject Pulzium...less of a concern for Kynapid, the FDA said. The FDAs Cardiovascular...atrial fibrillation, FDA drug reviewers expressed...the drugs safety. Kynapid caused two cases of...
- Additional Clinical Trial to be Conducted for KYNAPID Under FDA Special...
- Press release article from: PR Newswire August 10, 2009 700+ words
...extended discussions with the FDA to define the best regulatory path forward for KYNAPID. Under the Special Protocol...SPA) process, the FDA has agreed that the design...for approval from the FDA Cardiovascular and Renal Drugs Advisory Committee, KYNAPID has demonstrated consistent...
- FDA Advisory Committee Recommends Approval of KYNAPID(TM) for Acute Atrial...
- Press release article from: PR Newswire December 11, 2007 700+ words
...FDA) has recommended that the FDA approve KYNAPID(TM), the intravenous formulation...favour of recommending to the FDA that KYNAPID be approved for the rapid conversion...FDA. An action further to the FDA review of KYNAPID is expected on or before January...
- Cardiome and Astellas Announce Receipt of FDA Approvable Letter for KYNAPID(TM).
- Newspaper article from: Biotech Week August 27, 2008 700+ words
...and Drug Administration (FDA) for KYNAPID(TM) (vernakalant hydrochloride...the action letter, the FDA informed the sponsor...completed its review of the KYNAPID NDA and that the application...considering approval, FDA requires additional information...
- Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For KYNAPID(TM).
- Press release article from: PR Newswire August 11, 2008 700+ words
...and Drug Administration (FDA) for KYNAPID(TM) (vernakalant hydrochloride...the action letter, the FDA informed the sponsor...completed its review of the KYNAPID NDA and that the application...considering approval, FDA requires additional information...
- FDA's Kynapid stall narrows its label.(Wednesday, August 12)
- Newspaper article from: BioWorld Week August 17, 2009 700+ words
...call recently. Despite a positive advisory panel review, the FDA--nearly seven months after the January 2008 PDUFA date...additional clinical data for intravenous vernakalant (branded Kynapid) for therapeutic cardioversion in atrial fibrillation. And...
- Kynapid Approvable Letter Sends Cardiome's Shares Tumbling.
- Magazine article from: BIOWORLD Today Young, Donna August 12, 2008 700+ words
...decision from the FDA about Kynapid (vernakalant...recommendation by the FDA's Cardiovascular...Committee to approve Kynapid as a pharmacologic...explained. While Kynapid was shown to be effective...fibrillation, the FDA had some concerns...
- Yet Another Pivotal Trial Kynapid Stall Narrows Label But Cardiome Forges Ahead.
- Magazine article from: BIOWORLD Today Boggs, Jennifer August 12, 2009 700+ words
...positive advisory panel review, the FDA -- nearly seven months after...intravenous vernakalant (branded Kynapid) for therapeutic cardioversion...debated how to respond to the FDA's demands, the I.V. drug...protocol assessment with the FDA to assure approval upon positive...