Adamis Pharma files NDA at FDA for naloxone pre-filled single dose syringe product to treat opioid overdose.
Adamis Pharma files NDA at FDA for Adamis Pharmaceuticals Corporation announced the submission of a New Drug Application (NDA) to the FDA for its naloxone pre-filled single dose syringe (PFS) product candidate. This injection is designed for the treatment of an opioid overdose. Adamis submitted the NDA pursuant to Section 505(b)(2) of the Food, Drug & Cosmetic Act. Naloxone is an opioid antagonist used to treat narcotic overdoses.
Naloxone, which is generally considered the drug of choice for immediate administration for opioid overdose, blocks or reverses the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness. Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl.
.Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins