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Today's FDA Final Approvals
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For more information on the FDA, please visit FDA.gov
The latest announcements from the Center for Drug Evaluation and Research:
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August 8 - FDA issues an Information for Healthcare Professionals sheet for Amiodarone and Simvastatin.
Drug Information
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July 31 - Viapro 375mg Capsules recalled since it contained a potentially harmful analog of Sildenafil.
MedWatch Safety Information
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July 30 - FDA issues Complete Response letters ordering Safety Labeling Changes under FDAAA for Aranesp, Epogen, and Procrit.
Drug Information
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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
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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
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July 17 - FDA updates healthcare professionals about recent changes made to the prescribing information for micro-bubble contrast agents.
Drug Information
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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
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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
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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
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July 9 - FDA revises its process for responding to drug applications.
FDA News
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July 8 - FDA issues an Information for Healthcare Professionals sheet for fluoroquinolone antimicrobial drugs.
Drug Information
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June 30 - Novartis changes sections of Myfortic prescribing information based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with Myfortic.
MedWatch Safety Information
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June 30 - FDA approves the first generic versions of Risperdal (risperidone) tablets to treat schizophrenia, bipolar disorder, and other psychiatric conditions.
FDA News
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June 17 - FDA warns individuals and firms to stop selling fake cancer "cures"
FDA News
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June 16 - FDA issues an Information for Healthcare Professionals sheet for antipsychotics.
Drug Information
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June 12 - FDA releases its third issue of the
FDA Drug Safety Newsletter.
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June 11 - ETHEX Corporation voluntarily recalls a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness.
MedWatch Safety Information
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June 6 - FDA issues a Follow-up to the March 27, 2008 Communication about the Ongoing Safety Review of Regranex (becaplermin).
More Information
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June 4 - FDA issues an Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia).
More Information
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May 30 - FDA has issued a public health advisory to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008.
FDA News | Public Health Advisory | Podcast | Availability
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May 28 - FDA proposes a new rule to provide updated information on the use of prescription drugs and biological products during pregnancy and breast-feeding.
FDA News
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May 20 - FDA approves Entereg (alvimopan) to help restore bowel function following surgery.
FDA News
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May 16 - FDA approves new Medication Guide and Label for Varenicline (marketed as Chantix).
Drug Information
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May 16 - FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic).
Drug Information
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May 14 - Aprotinin Injection (marketed as Trasylol): Manufacturer Removes Remaining Stocks of Trasylol.
FDA News and Information.
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May 14 - Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass.
Information
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May 14 - FDA releases a Follow-up to the November 14, 2007, Communication about the Ongoing Safety Review of Cefepime (marketed as Maxipime).
Information
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May 12 - FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use.
MedWatch Safety Information
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May 2 - The prescribing information for Enbrel (etabercept) is revised to include a boxed warning about infections.
MedWatch Safety Information
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News and Announcements
