Akorn Sees A $10m Increase In FDA Compliance Expenditure

Akorn’s second-quarter results show a drop in sales despite the launch of three new products. The company expects a $10m increase in FDA compliance and data-integrity assessment expenditures because of a warning letter issued over its Somerset manufacturing facility.

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Increased cost in FDA compliance and settlement of shareholder lawsuits reflect in Akorn’s Q2 FY19 results • Source: Shutterstock

Anticipated costs for addressing problems identified at its US manufacturing facility in Somerset, New Jersey, in a warning letter issued by the US Food and Drug Administration have led Akorn to increase by $10m to $50m its expected outlay this year on FDA compliance and data-integrity assessment.

And the US injectables and ophthalmics specialist having reached a $74m non-binding agreement with lead plaintiffs in a securities class-action...

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