Search results for "FDA update"

Results 1 - 10 of about 49 for "FDA update".

Automated reprocessors validated for use in specific duodenoscopes

System 83 Plus automated endoscope reprocessors (AERs) by Custom Ultrasonics may now be used to process certain duodenoscopes, the FDA announced on April 10. ... The FDA determined that the data show that the AERs can achieve high-level disinfection of
April 2018

IBS-D drug should not be prescribed to patients without gallbladders

The FDA suggests that clinicians should consider alternatives to eluxadoline in this population. ... Eluxadoline (Viberzi), a drug used to treat irritable bowel syndrome with diarrhea, should not be used in patients without gallbladders, the FDA warned
March 2017

Data show higher-than-expected rates of duodenoscope contamination

While the number of medical device reports associated with patient infections has declined by 62% since peaking in 2015, the FDA and duodenoscope manufacturers continue to address issues around device reprocessing. ... duodenoscope manufacturers
December 2018

Updated design, labeling cleared for duodenoscope

On Feb. 7, the FDA cleared the updated design and labeling for the Pentax Medical Duodenoscope Model ED-3490TK. ... The FDA continues to monitor the association between reprocessed endoscopes and transmission of infectious agents.
February 2018

Generic form of mesalamine approved

On June 5, the FDA approved the first generic form of mesalamine delayed-release oral tablets USP (1.2 g).
June 2017

FDA approves new drug for travelers' diarrhea

The FDA has approved the oral antibacterial rifamycin (Aemcolo) to treat adults with travelers' diarrhea, the agency announced on Nov. ... 16. Compared to placebo, the drug significantly reduced symptoms in a randomized controlled trial of 264 adults
November 2018

Boxed warning added to liver disease drug

The FDA announced on Feb. 1 that it will add a new boxed warning to highlight the correct dosing for obeticholic acid (Ocaliva). ... In addition, a new medication guide required by the FDA will inform patients about the issue.
February 2018

FDA places limits on OTC loperamide

To foster safer use of over-the-counter loperamide (Imodium), the FDA is implementing restrictions on its packaging. ... The FDA will continue to evaluate the drug's safety.
February 2018

New data show even higher rates of duodenoscope contamination

reprocessing failure, the FDA said in its update. ... The results show that improvements are necessary, and the FDA is exploring additional steps to reduce contamination rates.
April 2019

Proton-pump inhibitor recalled

One lot of pantoprazole sodium for injection (40 mg per vial) was recalled from hospitals nationwide, the FDA announced on Dec.
January 2018

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