Article: Warning issued on Cephalon painkiller.

Article: Fast-acting pain lozenge is approved: The FDA allows ...
Philadelphia Inquirer (Philadelphia, PA);  September 26, 2006 ;     700+ words ... ... in anticipation that the FDA would approve the drug ... after-hours trading. Fentora is a successor cancer ... name Actiq. In June, the FDA gave Fentora an "approvable" letter ... Cephalon: In April, the FDA approved Vivitrol, a once ...

Article: Cephalon Receives FDA Approval of FENTORA(TM) ...
PR Newswire;  September 25, 2006 ;     700+ words ... ... Food and Drug Administration (FDA) to market FENTORA(TM) (fentanyl buccal tablet ... underlying persistent cancer pain. FENTORA is the first and only buccal tablet ... Cephalon this year. Cephalon expects FENTORA to be available in the United States ...

Article: FDA to consider Fentora sNDA on May 6.
Pharma Marketletter;  February 4, 2008 ;     465 words ... ... Drug Application for Fentora (fentanyl buccal tablet ... pain. In addition, the FDA notified the company ... are pleased that the Fentora application remains on schedule with an FDA action date of September ... regulatory operations. "Fentora is the first medication ...

Article: Cephalon Announces FDA Advisory Committee Recommendation ...
Health & Medicine Week;  May 19, 2008 ;     700+ words ... ... Administration (FDA) voted not to recommend ... expanded label for FENTORA(R) (fentanyl ... a>). FDA action on the FENTORA supplemental new ... of the sNDA for FENTORA, which was submitted ... November 2007. The FDA is not required ...

Article: FDA: Wider Use of Fentora Could Mean More Abuse.
BIOWORLD Today;  May 6, 2008 ;     700+ words ... ... the agency. The FDA wants the panel ... medical need for Fentora in non-cancer ... However, the FDA said, in the "short time that Fentora has been on the ... filled first, the FDA said. However ... with Actiq and Fentora during year 2007 ...

Article: US FDA approves Cephalon's Fentora.(approval for ...
Pharma Marketletter;  October 2, 2006 ;     700+ words ... ... Drug Administration has approved US drugmaker Cephalon's Fentora (fentanyl buccal tablet) [C-II] for the management of ... to be marketed by Cephalon this year. The company says that Fentora will be available across the USA during the first week of October ...

Article: Watson Files FDA Application for Generic ...
PR Newswire;  April 24, 2008 ;     700+ words ... ... Drug Administration (FDA) seeking approval to ... version of Cephalon's FENTORA(R) C-II (fentanyl ... applicant to file an ANDA for FENTORA(R) containing a paragraph ... development efforts and FDA or other regulatory agency ... December 31, 2007. FENTORA(R) is a registered ...