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…
Source: bizjournals.com Health Care:Pharmaceuticals headlines - Category: Pharmaceuticals Authors: Max Stendahl Source Type: news
More News: Diabetes | Diabetes Type 2 | Endocrinology | Health Management | Pharmaceuticals | Warnings