FDA Rejects Able Labs’ Plan To Return Products To Market
This article was originally published in The Pink Sheet Daily
Executive Summary
Able plans to sell its business and assets rather than pursue full resubmission of its ANDAs.
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Trenton, N.J. federal bankruptcy court judge will hear argument on Oct. 19; the deal is contingent upon several items.
Able Labs Awaits Bankruptcy Court Approval For Sale Of Assets To Aurobindo
Trenton, N.J. federal bankruptcy court judge will hear argument on Oct. 19; the deal is contingent upon several items.
Able Labs To Withdraw Seven Approved ANDAs, Recall All Products
The company is concerned about the reliability of data underlying the applications and says further ANDA withdrawals could be forthcoming. Able also is suspending manufacturing and distribution operations and recalling all of its products.