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CDER News Items 2008
• May 2. The prescribing information for Enbrel (etabercept) is revised to include a boxed warning about infections. MedWatch Safety Information.
• April 29. FDA approves Amitiza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over. FDA News
• April 28. Actavis Totowa LLC recalls all strengths of Digitek (digoxin tablets, USP), a drug used to treat heart failure and abnormal heart rhythms. MedWatch Safety Information
• April 25. FDA approves Relistor (methylnaltrexone bromide) for opioid-induced constipation.
• April 22. FDA approves Cimzia (certolizumab pegol) to treat Crohn's disease
• April 16. FDA issues "Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg."
• April 10. FDA issues a Communication About an Ongoing Safety Review of CellCept and Myfortic. Drug Information
• April 9. Schwarz Pharma recalls Neupro, a transdermal delivery system used to treat early stage Parkinson’s disease, at the end of April. MedWatch Safety Information
• April 9. Pfizer informs healthcare professionals and patients of updated safety information in the labeling for Exubera, a short-acting insulin. MedWatch Safety Information
• April 9. Cubist Pharmaceuticals, Inc. informs healthcare professionals that a potentially significant impurity has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. MedWatch Safety Information
• April 2. GlaxoSmithKline informs healthcare professionals of changes to the prescribing information for Relenza regarding information from postmarketing reports. MedWatch Safety Information
• March 27. FDA issues a Communication about an Ongoing Safety Review Regranex (becaplermin). Information
• March 27. FDA issues an Early Communication about an Ongoing Safety Review of Ziagen (marketed as Abacavir) and Videx (marketed as Didanosine). Information
• March 27. FDA issues an Early Communication about an Ongoing Safety Review of Montelukast (marketed as Singulair). Information
• March 26. FDA releases information on Risk Evaluation and Mitigation Strategies (REMS).
• March 21. B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). MedWatch Safety Information
• March 21. FDA issues an FDA Alert and Information for Healthcare Professionals Sheet for Prezista (darunavir ethalolate). Drug Information
• March 18. FDA issues an Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler). Information
• March 18. FDA releases its second issue of the FDA Drug Safety Newsletter.
• March 18. FDA releases a progress report on the New Molecular Entities (NME) Post-Marketing Safety Evaluation Pilot Program. Information
• March 12. Amgen and FDA notify healthcare professionals of changes to the Boxed Warnings/Warnings for increased mortality and/or tumor progression section of the Aranesp and Epogen/Procrit labeling. MedWatch Information
• March 12. FDA and Tibotec Therapeutics notify healthcare professionals of changes to the Warnings section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. MedWatch Information
• March 11. FDA issues an Information for Healthcare Professionals sheet and Public Health Advisory for Tussionex Pennkinetic Extended-Release Suspension, a long-acting hydrocodone-containing cough product. Drug Information
• March 6. FDA releases information on two tests that manufacturers and regulators can use to screen heparin for contaminants. Information
• March 5. FDA updates safety information for long acting beta agonists (LABA). Information
• February 29. FDA issues a Public Health Advisory highlighting the correct use of Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) capsules. Public Health Advisory
• February 28. Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions. Information
• February 28. FDA approves Nexium (esomeprazole magnesium) for use in children ages 1-11 years. Drug Information
• February 15. PriCara and Sandoz Inc. recall all lots of 25 mcg/hr Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches sold in the United States. MedWatch Safety Information.
• February 11. FDA announces that Baxter Healthcare Corp. has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension. FDA News
• February 6. FDA approves the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis. FDA News
• February 6. FDA takes action to stop the marketing of unapproved injectable drugs containing colchicine. FDA News
• February 1. FDA issues a Public Health Advisory and Information for Healthcare Professional sheet for Chantix (varenicline). Drug Information
• January 31. FDA issues an FDA Alert and Information for Healthcare Professional sheet for suicidality and antiepileptic drugs. Information
• January 25. FDA issues an Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor). FDA Statement
• January 25. Clarification of Recent FDA Initiatives Affecting OTC Drugs. Information
• January 24. Bayer and FDA inform healthcare professionals of the market withdrawal of the current liquid formulation of Leukine (sargramostim) MedWatch Information
• January 18. FDA approves additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label. FDA News
• January 17. FDA issues a Public Health Advisory recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years. FDA News | Public Health Advisory
• January 16. FDA issues a Public Health Advisory on edetate disodium (marketed as Endrate and generic products). Drug Information
• January 15. FDA approves Tysabri (natalizumab) to treat moderate-to-severe Crohn's Disease. FDA News
• January 9. FDA takes action against compounded menopause hormone therapy drugs. FDA News
• January 7. FDA issues an FDA Alert and Information for Healthcare Professionals sheet for bisphosphonates. Drug Information
• January 3. FDA receives new data on risks of anemia drugs known as erythropoiesis-stimulating agents, or ESAs. FDA News | Communication about an Ongoing Safety Review
News Items 2007
News Items 2006
News Items 2005
News Items 2004
News Items 2003
News Items 2002
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Date updated: May 2, 2008 |
