Braeburn resubmits new drug application for experimental opioid use disorder treatment

Montgomery County drug developer Braeburn Inc. has resubmitted its new drug application for Brixadi, the firm's experimental therapy for opioid use disorder. The resubmission is in response to the FDA's rejection of the new drug candidate in December. The FDA cited deficiencies found during an inspection at a third-party manufacturing facility as its main reason for not approving the therapy at that time. Braeburn representatives said the company has worked closely with the unnamed third-party…
Source: bizjournals.com Health Care:Biotechnology headlines - Category: Biotechnology Authors: Source Type: news