Able ANDA approvals withdrawn
Executive Summary
FDA withdraws approval of ten ANDAs held by Able effective Aug. 29. The move follows the agency's rejection of Able's proposal to return its products to market by re-validating product development data under existing ANDAs (1"The Pink Sheet" Aug. 22, 2005 In Brief)...
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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)...
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