Third Akorn sterile drug plant hit by FDA as new CEO lays out blueprint for a better future

Akorn Pharmaceuticals, which had a $4.3 billion buyout by Fresenius tank last fall, just can’t seem to catch a break. Just weeks after being hit with an FDA warning letter for its manufacturing operations in Illinois—problems that led to the death of the deal—Akorn today reported that it has received a citation on its third U.S. facility While the four observations were relatively minor, it was a downer on the same day the new CEO Douglas Boothe was telling the market Akorn is ready to move past its regulatory challenges and buyout debacle with Fresenius. “Our recent financial results reflect the many challenges that have impacted our business of late, including increased competition for many of our generic and promoted products, supply issues, and regulatory and legal challenges,” Boothe said in a statement as the company reported fourth-quarter earnings. “Despite these significant headwinds, we have strong fundamentals to build upon … I look forward to providing updates in the coming months on our go-forward strategy and plan to rebuild value for all of our stakeholders.”

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