Month: May 2016

FDA Approves Monthly Zinbryta Injection For Patients With Multiple Sclerosis

Patients with multiple sclerosis (MS) can now get monthly Zinbryta injections as the U.S. Food and Drug Administration approved its use. The FDA approved on May 27 the use of Zinbryta (daclizumab) for adults suffering from worsening forms of MS. Zinbryta is a self-administered long-acting monthly injection manufactured by Biogen, Inc. Prior to the approval, …

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Cancer Drugs Are The Least Likely to Receive FDA Approval

A massive new study of drug candidates sheds light on which experimental therapies are most likely to eventually reach the market. The report was compiled by biotech’s largest trade association, the Biotechnology Innovation Organization (BIO), with the help of business intelligence firms BioMedTracker and Amplion, and it found that drugs for blood disorders have the …

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Safety Troubles in Hospital Compounding Pharmacies

We wrote yesterday about contamination at the pharmacy of the NIH Clinical Center in Bethesda. Other big hospitals, judging by media reports, also may need to look at their pharmacy operations, especially when they compound ingredients together into custom drugs for patients. A major hospital in a San Diego, Calif., suburb may have exposed more than 7,300 …

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FDA issues safety alert for fluoroquinolones

Agency warns that serious adverse effects generally outweigh benefits for patients with sinusitis, bronchitis, and uncomplicated UTIs. FDA announced that it will require drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated with new safety information. FDA is warning that serious adverse effects with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients …

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FDA Requests Compounding Pharmacy Recall Products

The FDA is warning health care professionals and patients about products intended to be sterile that were compounded by Medaus Inc.The administration has formally requested that the compounding pharmacy, which is based in Birmingham, Alabama, recall products due to sterility concerns.Administering nonsterile products that are supposed to be sterile may cause serious infections or death.The …

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SOS Telecom, Inc. Recalls New Unapproved Drugs Marked as Dietary Supplements

SOS Telecom, Inc. of Bayside, NY is voluntarily recalling all lots of the following products to the consumer level because these products were tested by the FDA and found to contain Sildenafil, and analogs of Sildenafil. Sildenafil is a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED), making …

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PharMEDium Recalls Compounded Bupivacaine Products

PharMEDium Services, LLC, of Lake Forest, Illinois, has voluntarily recalled hundreds of sterile preparations compounded with a single recalled lot of Fresenius KabiSensorcaine-MPF (bupivacaine HCl) to the hospital level. The complete 81-page list of recalled products can be found on the PharMEDium website. On April 25, Fresenius Kabi recalled the specific lot at issue after identifying particulate …

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Federal Judge Enters Order of Permanent Injunction Against Compounding Pharmacy Owner

A federal judge has entered an order of permanent injunction on behalf of FDA against Paul W. Franck, the owner and operator of numerous compounding pharmacies in Florida over the past 20 years, FDA said in an April 29, 2016 press announcement. Franck allegedly “manufactured and distributed drug products that were adulterated and misbranded in violation …

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New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations

Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products. First, however, a little bit of historical context might be helpful.  In late 2013 Congress passed a law called the Drug Quality and Security Act (DQSA).  Among other things, DQSA created …

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