Free Newsletter
FDA blocks new Fentora uses
The FDA to Cephalon: Get a better risk-communication program. That's what lies between the drugmaker and new indications for its painkiller Fentora. As you know, Fentora is already emblazoned with warnings of potentially life-threatening risks. Cephalon has reported five deaths among Fentora patients, from adverse reactions or overdose.
Already approved for breakthrough cancer pain, Fentanyl was up for FDA consideration to treat breakthrough pain in patients with chronic lower back and nerve pain. But an advisory panel voted 17-3 against broadening the use of Fentora, citing the potential for misuse among even more patients.
The company said it will continue to educate caregivers and patients to make sure the drug is appropriately prescribed--but offered no other word yet on how it plans to answer the FDA's concerns. Though the drug was introduced only under strict guidelines for use, in its some two years on the market, scrips have grown to the point that more than 80 percent of patients take it off-label.
- read the story in the Philadelphia Inquirer
Related Articles:
FDA panel rejects broader Fentora use
Expert panel to mull broader Fentora use
FTC sues Cephalon for blocking generics
New warning for off-label Fentora (Sept 2007)
Cephalon CEO, Frank Baldino
Comments
Post new comment
Paid Research Reports
- The Specialty Pharma Market Outlook: Key players, new company growth models and emerging opportunities
- Investigating Clinical Trial Costs: Comparative analysis of trial cost components in key geographies
- Clinical Trial Recruitment Strategies: Optimizing patient recruitment and retention in late stage clinical trials
- Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies
- Stakeholder Opinions: Vaccines in Emerging Markets (Asia) - Opportunities in China, India, South Korea and Taiwan
- Big Pharma Performance Before, During and Beyond the Global Recession





