Search results for "FDA update"
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
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
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
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
Endoscopic spray device approved to be marketed to treat GI bleeding
The FDA has permitted marketing of the Hemospray device to treat most types of upper or lower GI bleeding, the agency announced on May 7.
May 2018
New HCV drug combo approved
The FDA announced on July 18 that it has approved a new drug combination to treat adults with chronic hepatitis C virus (HCV) genotypes 1 through 6 who have mild or ... Due to concerns about hepatitis B virus (HBV) reactivation in co-infected patients,
July 2017
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
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 update
The FDA recently authorized marketing of a new device designed to remove dead pancreatic tissue. ... The system should not be used in patients with known or suspected pancreatic cancer, and a boxed warning will emphasize this point, the FDA said.
January 2021