Able to divest businesses
Executive Summary
FDA rejects Able Labs' plan to return drugs to market by re-validating product development data included in existing ANDAs and says the company would need to resubmit the ANDAs to FDA for a complete review with new data. The process would take up to 18 months, leading Able to state that its plan for reorganization is not feasible. Able plans to sell its businesses to one or more third party purchasers rather than resume manufacturing. Problems stem from an FDA inspection showing Able did not meet established good manufacturing processes; the company announced a voluntary recall of its products in May (1"The Pink Sheet" May 20, 2005, p. 23)...