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news.Able Laboratories is to liquidate its assets after an FDA decision convinced the company's board of directors that it would not be able to return any of its products to the market.
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In a final attempt to get its products returned to the market quickly enough to save the business, Able had asked the FDA to wave its usual review process of the abbreviated new drug applications that the company was required to submit before it would be allowed to recommence production.
However, the FDA refused this request, and advised the company that the most expeditious re-launch of products would nevertheless require withdrawal, resubmission (with new data), and agency review of ANDAs for products that Able desired to manufacture in the future. In the view of Able’s management, FDA review of the ANDAs could take up to 18 months in each case.
In light of this, the company has decided that the best course of action is to cut its losses and sell the business as soon as possible. The company has also said that it considers it unlikely that shareholders will receive any proceeds from the sale of the company’s assets, as the proceeds are unlikely to cover its liabilities.
Able has been in increasing financial difficulty since it announced on May 23, 2005 that it was voluntarily recalling its products from the market, and ceasing manufacture, amid concerns about the falsification of data used to obtain FDA approval for the sale of its drugs.