Royce
Executive Summary
ANDAs for generic piroxicam were withdrawn because the company was "not able to prove to FDA's satisfaction that our explanations for certain discrepancies in these applications were correct," Royce said Dec. 30. "We withdrew the ANDAs rather than engage in lengthy discussions with the agency." "The Pink Sheet" (Dec. 20, 1993, T&G-15) misstated the reason for withdrawal of the applications