FDA Rejects Titan’s Probuphine Despite Positive Panel Vote
This article was originally published in The Pink Sheet Daily
FDA’s “complete response” letter for abuse-resistant buprenorphine for opioid dependence follows an advisory committee that aired concerns about efficacy and adequate dosing, as well as questioning the proposed Risk Evaluation and Mitigation Strategy.
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From the approval of AZT to the generic drug scandal, Frank Young oversaw many seminal events at US FDA while commissioner from 1984 to 1989. After leaving the agency, he managed the approval of the NDA for Braeburn's opioid dependence drug Probuphine. Young passed away following a short bout with cancer.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.
Part 1: Execs from rare disease-focused companies weighed in on investor sentiment during a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference.