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CDER News Items 2009
• May 5. FDA issues an Update about Suicidal Behavior and Ideation and Antiepileptic Drugs. Drug Information
• May 4. FDA updates information on the 2009 H1N1 Flu Virus. H1N1 Flu
• May 1. FDA approves pancrelipase (Creon Delayed-Release Capsules) for adult and pediatric patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), chronic pancreatitis, and other conditions. Drug information
• April 30. FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)
• April 29. FDA updates information on the 2009 H1N1 Flu Virus. Information
• April 22. FDA updates action on Plan B (levonorgestrel) tablets. FDA Statement
• April 14. FDA imposes restrictions on Coast IRB due to violations. FDA News
• April 14. FDA issues Information for Healthcare Professionals: Ceftriaxone (marketed at Rocephin and generics) Information
• April 9. FDA adopts an interim plan to avoid shortage of a medically necessary opioid. FDA News
• April 8. Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announces that it has begun a voluntary, phased withdrawal of the product from the U.S. market. FDA Statement
• March 31. FDA acts to halt marketing of certain unapproved prescription narcotic drugs. FDA News
• March 19. FDA issues Information for Healthcare Professionals: Risk of Transmission of Blood-borne Pathogens from Shared Use of Insulin Pens. Information
• March 10. FDA issues position on allowing patients with ALS access to Iplex under an IND. Information
• March 5. Public Health Advisory: Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Information
• February 25. FDA takes new regulatory action against Ranbaxy’s Paonta Sahib plant in India. FDA News
• February 23. FDA issues Information for Healthcare Professionals for Zonisamide. Information
• February 19. FDA issues Updated Safety Information about Raptiva (efalizumab). Information
• February 9. FDA to meet with drug companies about REMS for certain opioid drugs. Information
• February 4. FDA issues an Early Communication about an Ongoing Safety Review Xigris (Drotrecogin alfa [activated]) Drug Information
• January 26. FDA issues an Early Communication about an Ongoing Safety Review of clopidogrel bisulfate (marketed as Plavix) Drug Information
• January 16. Follow-up to FDA Public Health Advisory Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditionso the March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair) Information
• January 13. Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair) Information
• January 8. Follow-up to the January 25, 2008 Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor). Information
• January 5. On Dec. 31, 2008, Celgene issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. MedWatch Safety Alert
News Items 2008
News Items 2007
News Items 2006
News Items 2005
News Items 2004
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News Items 2002
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Date created: May 1, 2009 |
