Month: June 2016

FDA approves Epclusa for treatment of chronic Hepatitis C virus infection

The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a …

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FDA panel to vote whether diabetes drug cuts cardiac death

(Reuters) – An advisory panel to the U.S. Food and Drug Administration will be asked to vote next week on whether a diabetes drug made by Eli Lilly & Co and Boehringer Ingelheim cuts the risk of cardiovascular death, according to documents posted on the agency’s website on Friday. The documents were published ahead of …

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Two Alabama pharmacists sentenced in case of tainted drugs linked to 9 deaths

Two former Jefferson County pharmacists were sentenced to federal prison – one to 12 months and the other 10 months – for their roles in the distribution of tainted drugs in 2011 that authorities say contributed to the deaths of nine patients at various Birmingham-area hospitals who developed bloodstream infections. The two men had been …

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Hospital Upgrades Cleanroom for a fraction of the anticipated time and cost.

The Situation:  A hospital pharmacy had an existing cleanroom that was not meeting the USP<797> requirements(1) for an ISO class 7 (2) grade cleanroom.  The existing cleanroom was deficient in both Air Changes Per Hour (ACPH) and lacked low wall returns.  The Challenge:   After multiple meetings with pharmacy staff, facilities, maintenance, engineering and architectural, it …

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FDA Approves Cholera Vaccine

FDA approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults, the agency said in a June 10, 2016 press announcement. Although cholera is rare in the United States, FDA said travelers to countries with poor sewage and sanitation treatment are at risk for the disease. Vaxchora is the only FDA-approved vaccine …

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Drug company recalls popular vitamins for salmonella concerns

NORTHRIDGE, CA – A number of Nature Made vitamins are being recalled due to possible salmonella contamination. The recalled products were distributed nationwide to various major retailers. For a full list of recalled vitamin visit Nature Made’s website. The recalled products and lot numbers are: Nature Made Adult Gummies Multi vitamins: 1196071, 1196066 and 1205052 Nature Made Adult Gummies …

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Teva halts production at sterile injectables plant to address FDA concerns

Sterile injectable products are notoriously difficult to produce, and the FDA has little tolerance for plant issues that might lead to contamination. Just ask companies like Hospira and Mylan. Now, the FDA has found serious enough problems at a Teva sterile injectables plant in Hungary that it has banned most of its products from the …

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FDA approved ‘permanent’ birth control causing lifelong recurring pain

When it comes to effectively preventing unwanted pregnancies, women simply don’t have a lot of good options. Now, women who have turned to the permanent birth control procedure known as Essure in an effort to avoid the harmful effects of birth control pills, are finding that the alternative can actually be even worse.Essure is a small …

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Aseptic Technique

Definition Aseptic technique is a set of specific practices and procedures performed under carefully controlled conditions with the goal of minimizing contamination by pathogens. Purpose Aseptic technique is employed to maximize and maintain asepsis, the absence ofpathogenic organisms in the clinical setting. The goal of aseptic technique is to protect the patient from infection. Description All patients …

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