Trends-in-Medicine
	Lynne Peterson, Senior Writer Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter. Copyright©  2003 No articles may be reproduced without written permission of the publisher. Return Home
					August 2003 Issues What to Expect with FDA PDUFA Timelines and Complete Response Letters - Quick Pulse Summary: A senior FDA official recently discussed PDUFA dates and regulatory timelines for CDER and CBER with Trends-in-Medicine. His answers to questions about PDUFA dates and Complete Response letters may help in interpreting what some companies are saying about the approvability of their drugs and biologic agents. CBER has already starting issuing Complete Response letters instead of approvable/non-approvable letters, and CDER is mandated by Congress to do the same. AstraZeneca's Crestor Summary: Sales of AstraZeneca's new statin, Crestor, are expected to grow very slowly. Cardiologists are likely to use it much as they would any other statin, but there may be little initial use by family practice doctors, who may approach it cautiously. Doctors do not appear worried about proteinuria or hematuria with Crestor, and they do not believe they are class effects. Crestor use is likely to cut into sales of Pfizer's Lipitor but not Pfizer's Zetia. Canadian pharmacists report extremely slow sales of Crestor, even in Saskatchewan where government coverage started July 1, 2003.
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