AstraZeneca PLC
13 February 2003
AstraZeneca Submits Information Amendment
For CRESTOR(R)(rosuvastatin calcium) NDA to FDA
AstraZeneca announced today the submission of an information amendment to its
New Drug Application (NDA) for CRESTOR(R) (rosuvastatin calcium) Tablets in
response to the US Food and Drug Administration (FDA) approvable letter of May
2002.
The additional data provide further support for the proposed use of CRESTOR(R)
Tablets for the treatment of patients for the management of
hypercholesterolaemia, mixed dyslipidaemia and isolated hypertriglyceridaemia.
13 February 2003
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