Astellas faces new delay for Advagraf approval
Japan's Astellas Pharma has run into a new roadblock in its pursuit of regulatory approval of Advagraf, its second generation version of the blockbuster transplant drug Prograf. The FDA has raised questions about the safety and efficacy of the drug for use in liver transplants. Last March the FDA issued an action letter regarding Advagraf for kidney transplants. The agency's action letters typically mean at least a six month delay before regulators will approve it.
Advagraf is already approved in Europe. Prograf earned $2 billion in sales last year.
- read the story in Yahoo News
Related Articles:
Astellas faces delay gaining crucial Advagraf approval
Astellas inks $537M deal for Agensys
Be the first to comment Rate it:
Comments
Post new comment
Paid Research Reports
- Leading Drug Delivery Companies and Technologies: Competitive landscape, company profiles and technological developments
- Drug Repositioning Strategies - Serendipity by design
- eHealthInsight Series: Online Patient Recruitment Strategies - Optimizing the clinical trial process
- Pricing & Reimbursement - Seven Major Markets Update
- Innovative Clinical Trial Design and Management: Trends, success stories and impact upon R&D budgets