Pharmaceutical Basics
Executive Summary
Sixty-three ANDAs for 31 products held by PBI are being withdrawn due to untrue statements of material fact and lack of substantial evidence of effectiveness, FDA announced in July 10 Federal Register. In November 1991, PBI said that it would withdraw the 63 ANDAs. PBI also agreed to a Class II recall of 30 of those drug products ("The Pink Sheet" Nov. 18, 1991, T&G-8).
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Sixty-three ANDAs for 31 products held by PBI are being withdrawn
due to untrue statements of material fact and lack of substantial
evidence of effectiveness, FDA announced in July 10 Federal
Register. In November 1991, PBI said that it would withdraw the 63
ANDAs. PBI also agreed to a Class II recall of 30 of those drug
products ("The Pink Sheet" Nov. 18, 1991, T&G-8). |