FDA to Review 2 Abuse-Deterrent Opioids
February 16th 2015The FDA recently accepted for review New Drug Applications for Collegium Pharmaceuticals' extended-release oxycodone formulation (Xtampza ER) and Pfizer's extended-release oxycodone hydrochloride and naltrexone hydrochloride (ALO-02), a pair of opioid analgesics with abuse-deterrent properties.
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FDA Clears New Transcarotid System to Reduce Stroke Risk
February 10th 2015The FDA has granted 510(k) clearance to Silk Road Medical's Enroute Transcarotid Neuroprotection System (TNS), a first-in-class device to restore normal blood flow to narrowed carotid arteries during carotid angioplasty and stenting.
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