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news.Able Laboratories has said that it will evaluate a variety of strategic options, including the possibility of filing for bankruptcy, having received notification from the FDA that its laboratory and manufacturing practices violated safety standards.
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However, the New Jersey-based generic drugmaker will have to follow this new course of action without its chief executive. The company reported the resignation of its interim CEO, Robert Mauro, a day before news of the FDA letter.
Able Labs temporarily suspended product shipments last month following quality control inspections by US regulators. The company has now lost over 85% of its stock value since the resignation of its previous chairman and CEO, Dhananjay Wadekar, who left on May 18.
In a statement, the company acknowledged that the product recall and the suspension of its manufacturing activities “has had, and will continue to have, a material adverse effect on the company’s results of operations and financial position.”
Able said that it would immediately begin seeking an appropriate replacement to lead the company in addressing its regulatory issues. Meanwhile, day-to-day activities are expected to continue to be overseen by the board of directors and carried out by the company’s senior management team and its retained consultants.
The company is also said to be working with the FDA to resolve the outstanding regulatory problems.