FDA News Briefs for Friday, February 2, 2018February 2, 2018
These Food and Drug Administration (FDA) developments came in this week:
FDA Approves First Vancomycin Oral Solution for C. difficile Diarrhea and S. aureus Colitis
The FDA has approved Firvanq (vancomycin hydrochloride; CutisPharma) oral solution for the treatment of Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients. Firvanq is the first FDA-approved vancomycin oral liquid product indicated for these uses. More Information.
FDA To Curb Misuse of OTC Antidiarrheal Imodium
The FDA has announced a new initiative to combat abuse and misuse of the over-the-counter (OTC), opioid-based antidiarrheal medication loperamide, which the agency describes as a growing problem that is placing individuals at risk for cardiac dysrhythmia and death. Loperamide is sold under the brand name Imodium (Johnson & Johnson), it is also sold under retail store brands, and as generics. More Information.
FDA Class I Recall: AirLife Humidification Chamber and Heated Breathing Circuit Kits
Vyaire Medical has recalled certain lots of the AirLife Humidification Chamber and Heated Breathing Circuit Kits due to a manufacturing error that may cause parts of the chamber to split apart into layers, allowing water to overflow the chamber and to back up into the patient breathing circuit. More Information.