FDA Rejects Zimhi NDA Again Citing New Issues
In the CRL, the FDA stated that the NDA could not be approved in its present form due to new issues pertaining to Chemistry, Manufacturing and Controls.
Poisoning/overdose
FDA: Diphenhydramine Overdoses Linked to New Social Media Challenge
Diphenhydramine when taken at higher than recommended doses can lead to serious health complications.
Fatal Medication Error: Ordinary Negligence or Professional Malpractice?
The nurse mistakenly administered 120 milligrams of morphine to the wrong patient.
FDA Cracks Down on Websites Illegally Selling Opioids
The unapproved and misbranded opioids, which include tramadol and oxycodone, are being sold without a prescription.
FDA Warns of Hand Sanitizers in Food-Like Packaging
Reports received by the FDA include hand sanitizer sold in a pouch that resembled a snack.
MPR Weekly Dose Podcast Episode 48
Treatment shows promise for patients who had pneumonia associated with COVID-19; A COVID-19 test that may have given inaccurate results; Neck gaiters as face masks may actually spread the virus; Drug applications are halted by the FDA; And Narcan has it’s shelf life extended. Also, we recap drug pipeline news from the past week.
Extended Shelf Life Approved for Narcan Nasal Spray
Naloxone is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose.
Shift Occurring in Deadly Overdoses
Rx opioid prescriptions down; illicit drugs are dominant cause of lethal drug overdoses.
Bisphenol A Linked to More Asthma Symptoms in Young Boys
Study shows exposure to bisphenol A is associated with more asthma symptoms in low-income boys.
FDA Clamps Down on Companies Selling Hangover Treatments
None of the products mentioned in the warning letters have been evaluated by the FDA for their intended uses.
