FDA warned drug maker about Hayward manufacturing issues before drug rejection

Less than two months before the FDA rejected Intarcia Therapeutics ’ potential blockbuster treatment for type 2 diabetes last year, inspectors at the agency faulted the company for a litany of issues at its Hayward manufacturing plant and warned about potential drug contamination, an agency document shows. The manufacturing warning letter, known as a Form 483, o ffers new clues about why the FDA declined to approve Boston-based Intarcia’s drug in September 2017. Since that time, the company has…
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