Pfizer seeking Geodon label change
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryPfizer's Jan. 22 Geodon (ziprasidone) supplemental NDA seeks to include the drug's "lack of adverse effects on blood lipids and glycemic control" in labeling. The filing suggests Pfizer was successful in convincing FDA not to add an atypical antipsychotic class warning on the risk of diabetes. Pfizer submitted a proposal for the addition of "Geodon's metabolic advantages" instead of FDA's requested warning Nov. 24, 2003. The sNDA may be aided by a Jan. 27 statement from the American Diabetes Association that patients on Geodon and Bristol-Myers Squibb/Otsuka's Abilify (aripiprazole) are not at increased risk of diabetes. Lilly (Zyprexa), Janssen (Risperdal) and AstraZeneca (Seroquel) have all modified labeling per FDA's September 2003 request. Pfizer's sNDA is also looking to add "greater initial dosing flexibility" and modify labeling on Geodon's effect on heart rhythm, "providing a new perspective on the clinical relevance of this effect," the firm says. Labeling currently carries an extensive bolded warning on QT prolongation...
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