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Posted 16 days ago by Drugs.com
January 25, 2017 – Dublin, Ireland – Today, the U.S. Food and Drug Administration (FDA) approved Narcan Nasal Spray as a 2mg formulation for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. The 2mg dose is approved for use in opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts. This approval comes just over one year after the FDA approved the first-of-its-kind, ready-to-use, needle-free version of naloxone, Narcan Nasal Spray 4mg, which has been commercially available since February 2016 following expedited FDA review and approval. Narcan Nasal Spray 2mg and 4mg are concentrated naloxone nasal sprays providing ready-to-use emergency treatments of opioid overdose, inc ... Read more
Posted 30 Apr 2016 by Drugs.com
CANTON, Mass., April 26, 2016 (GLOBE NEWSWIRE) – Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced that the U.S. Food and Drug Administration (FDA) approved Xtampza ER (oxycodone) extended-release (ER) capsules CII, a twice-daily, oxycodone medication for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Xtampza ER is Collegium’s first product utilizing its proprietary DETERx® technology platform, and is designed to provide adequate pain control while maintaining its drug release profile after being subjected to common methods of manipulation including chewing and crushing the product prior to administration. The Xtampza ER label contains information supporting the administration of the product by sprinkling the capsule contents on soft foods or into a cup, and th ... Read more