Brae­burn pe­ti­tions FDA to re­voke Sublo­cade or­phan des­ig­na­tion

A cit­i­zen pe­ti­tion filed last week by law firm Good­win Proc­ter on be­half of Penn­syl­va­nia-based drug­mak­er Brae­burn calls on the FDA to re­voke the or­phan des­ig­na­tion grant­ed to In­di­v­ior’s opi­oid use dis­or­der treat­ment Sublo­cade (buprenor­phine ex­tend­ed-re­lease in­jec­tion).

“Sublo­cade is not now, nor was it ever a bona fide or­phan drug, par­tic­u­lar­ly since more than two mil­lion Amer­i­cans cur­rent­ly are af­flict­ed by opi­oid ad­dic­tion,” the pe­ti­tion states.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER