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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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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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April 29 - FDA approves Amitiza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over.
FDA News
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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
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April 25 - FDA approves Relistor (methylnaltrexone bromide) for opioid-induced constipation.
Information
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April 22 - FDA approves Cimzia (certolizumab pegol) to treat Crohn's disease
Information
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April 16 - FDA issues "Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg."
Information
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April 10 - FDA issues a Communication About an Ongoing Safety Review of CellCept and Myfortic.
Drug Information
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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
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April 9 - Pfizer informs healthcare professionals and patients of updated safety information in the labeling for Exubera, a short-acting insulin.
MedWatch Safety Information
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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
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April 2 - GlaxoSmithKline informs healthcare professionals of changes to the prescribing information for Relenza regarding information from postmarketing reports.
MedWatch Safety Information
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News and Announcements
