The FDA has recently taken an unprecedented step to kickstart the development of over-the-counter naloxone products. Last week the FDA took an unprecedented step to make the anti-overdose drug naloxone directly available to opioid users. Currently, naloxone requires a prescription. But in an effort to make approval for non-prescription versions of the drug easier for… Continue reading Inside The Push For Over-The-Counter Naloxone
Tag: FDA
FDA Tries To Blame Kratom In Newborn Withdrawal Case
The agency claims it is aware of four other NAS cases involving infants exposed to kratom in utero. A new case report published in the journal Pediatrics suggests that kratom was the cause of a newborn’s withdrawal symptoms. While the Food and Drug Administration (FDA) and other naysayers of the herbal supplement say this is a… Continue reading FDA Tries To Blame Kratom In Newborn Withdrawal Case
Psilocybin Trials For Depression Treatment Get Greenlight From FDA
The FDA has recognized the psychedelic compound’s therapeutic potential. The U.S. Food and Drug Administration has granted its “Breakthrough Therapy” designation to psilocybin-assisted treatment for depression. By giving psilocybin research its “Breakthrough Therapy” designation, the FDA is expediting the development and review of psilocybin—the psychedelic compound in “magic mushrooms”—based on the results of preliminary clinical… Continue reading Psilocybin Trials For Depression Treatment Get Greenlight From FDA
New Opioid 500 Times Stronger Than Morphine Nears FDA Approval
Sufentanil is currently used intravenously in operating rooms in tightly-controlled circumstances. The chair of an FDA advisory panel is speaking out against the approval of a powerful new opioid that is even stronger than fentanyl, but despite his public stances it appears likely that the FDA will approve the drug. “Opioids are substantially different than… Continue reading New Opioid 500 Times Stronger Than Morphine Nears FDA Approval
Will Naloxone Be Co-Prescribed With Opioid Painkillers In The Future?
While some states already require the co-prescription, the FDA is considering making it a requirement across the US. In an effort to decrease overdose deaths, doctors could soon be required to prescribe an opioid overdose antidote any time they prescribe prescription painkillers, according to Food and Drug Administration (FDA) Commissioner Scott Gottlieb. The idea… Continue reading Will Naloxone Be Co-Prescribed With Opioid Painkillers In The Future?
FDA May Ban Flavored E-Cig Products From Convenience Stores
If the ban becomes a reality, places like 7-Eleven, Circle K, Shell and Mobil would no longer carry flavored e-cig products. Continuing its crusade to push back on “epidemic” levels of young people vaping, the FDA is now considering whether flavored e-cigarette products should be limited to being sold in vaping shops. This would mean… Continue reading FDA May Ban Flavored E-Cig Products From Convenience Stores
E-Cig Maker Called Out For Putting Erectile Dysfunction Meds In Vape Juice
The FDA issued a warning to one e-cig maker that reportedly violated the Food, Drug, and Cosmetic Act. The FDA is casting a closer eye on HelloCig Electronic Technology, an e-cigarette manufacturer, after FDA researchers discovered that not only were the fruit-flavored products found to impair lung function in trials on mice, but the liquids… Continue reading E-Cig Maker Called Out For Putting Erectile Dysfunction Meds In Vape Juice
New Dosage Strength Of Opioid Addiction Drug Approved By FDA
The FDA commissioner noted that the approval will expand access for patients and reduce drug development costs. The U.S. Food and Drug Administration (FDA) approved a new dosage strength for a maintenance drug for the treatment of opioid addiction. Cassipa, which is a sublingual (applied under the tongue) film that combines the opioid treatment drug buprenorphine… Continue reading New Dosage Strength Of Opioid Addiction Drug Approved By FDA
FDA Cracks Down On Top E-Cig Brands To Curb Teen Vaping Epidemic
Around 1,300 warning letters have been sent to retailers of e-cigarettes found to be illegally selling e-cigarette products to minors. The Food and Drug Administration, concerned about the rising numbers of teenagers who “vape,” is cracking down on major e-cigarette brands to try and stop this trend. In a press release issued on Wednesday (Sept.… Continue reading FDA Cracks Down On Top E-Cig Brands To Curb Teen Vaping Epidemic
Stop Illegally Selling Opioids Online, FDA Warns
Over the summer, the FDA has issued similar warnings to 70 websites. The Food and Drug Administration issued a warning this week to the operators of 21 websites that the administration says sell mislabeled and illegal opioids to Americans. The websites, which are run by four companies, have been “illegally marketing potentially dangerous, unapproved, and… Continue reading Stop Illegally Selling Opioids Online, FDA Warns