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Wyeth's temazepam ANDA petition

Executive Summary

FDA denied Wyeth's request to make 10 and 20 mg liquid-filled soft gelatin caps ANDA-suitable because the firm's data "suggests that the pharmacokinetic performance" of the products "could be significantly different in the rate and extent of absorption" from Sandoz' Restoril 15 and 30 mg hard caps.
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