FDA admits it goofed when granting orphan status to an opioid addiction treatment

first_imgPharmalot FDA admits it goofed when granting orphan status to an opioid addiction treatment By Ed Silverman Nov. 8, 2019 Reprints @Pharmalot In an unusual move, the Food and Drug Administration has acknowledged a mistake and revoked orphan drug status for an opioid addiction treatment that was approved two years ago, clearing the way for another injection of buprenorphine to possibly reach the market.Specifically, the agency withdrew orphan designation and exclusivity for Sublocade, which was approved nearly two years and hailed as a potential game changer for combating the opioid crisis. But the move generated controversy because of a quirk in the law that critics complained should not have allowed the manufacturer, Indivior, to win orphan status and crowd out competitors. GET STARTED Jacquelyn Martin/AP What’s included? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Tags government agenciesopioidsSTAT+center_img Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. About the Author Reprints What is it? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. [email protected] Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Log In | Learn More Ed Silvermanlast_img

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