|
Today's FDA Final Approvals
|
|
|
|
|
|
For more information on the FDA, please visit FDA.gov
The latest announcements from the Center for Drug Evaluation and Research:
-
October 28 - FDA issues warning letters to Bayer HealthCare for illegally marketing two unapproved drugs.
FDA News.
-
October 16 - Ethex Corp and FDA notify healthcare professionals of a voluntary recall of three lots of dextroamphetamine sulfate 5mg tablets.
MedWatch Safety Information.
-
October 16 - FDA creates a consolidated web page with drug safety information for patients and health care professionals.
FDA News.
-
October 9 - FDA issues statement following CHPA's announcement on nonprescription over-the-counter cough and cold medicines in children.
FDA Statement.
-
October 7 - FDA issues an updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler).
Information.
-
September 26 - FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke.
MedWatch Safety Information.
-
September 18 - Covidien and Mallinckrodt Inc. inform healthcare professionals of important new safety information in prescribing Phosphocol P 32.
MedWatch Safety Information
-
September 16 - FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India.
Drug Information
-
September 12 - Genentech informs healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML).
MedWatch Safety Information
-
September 5 - FDA posts quarterly report of potential safety issues.
FDA News
-
September 4 - FDA announces that manufacturers of TNF-blocker drugs (Cimzia, Enbrel, Humira, and Remicade) must highlight the risk of fungal and serious opportunistic infections.
FDA News
-
August 25 - FDA updates the Information for Healthcare Professionals sheet for Tysabri (natalizumab).
Drug Information
-
August 21 - FDA issues an Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia).
Drug Information
-
August 18 - FDA updates the Information for Healthcare Professionals sheet for Byetta (exenatide).
Drug Information
-
August 13 - Watson Pharmaceuticals, Inc. issues a voluntary recall of one lot of 75mcg/hr Fentanyl Transdermal System patches.
MedWatch Safety Information
-
August 12 - FDA issues an Information for Healthcare Professionals sheet for Vivitrol (naltrexone).
Drug Information
-
August 8 - FDA issues an Information for Healthcare Professionals sheet for Amiodarone and Simvastatin.
Drug Information
-
July 31 - Viapro 375mg Capsules recalled since it contained a potentially harmful analog of Sildenafil.
MedWatch Safety Information
-
July 30 - FDA issues Complete Response letters ordering Safety Labeling Changes under FDAAA for Aranesp, Epogen, and Procrit.
Drug Information
-
July 29 - FDA reminds health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone.
MedWatch Safety Information
-
July 24 - FDA informs healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701.
MedWatch Safety Information
-
July 17 - FDA updates healthcare professionals about recent changes made to the prescribing information for micro-bubble contrast agents.
Drug Information
-
July 17 - Roxane Laboratories informs healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, a product used to treat hyperkalemia.
MedWatch Safety Information
-
July 14 - Genentech informs healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate.
MedWatch Safety Information
-
July 9 - Genentech reports that it received an increased number of complaints regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent.
MedWatch Safety Information
-
July 9 - FDA revises its process for responding to drug applications.
FDA News
-
July 8 - FDA issues an Information for Healthcare Professionals sheet for fluoroquinolone antimicrobial drugs.
Drug Information
Files with  are .pdf files.
You must have Adobe Acrobat to view these files.
Click here for free download from Adobe.
Search A Catalog of FDA Approved Drug Products from Drugs@FDA
Search Additions/Deletions for Prescription and OTC Drug Product Lists from FDA.gov
|
|
|
|
|
News and Announcements
