Megestrol acetate products, method of manufacture, and...

Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from hypericum

Reexamination Certificate

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C424S736000

Reexamination Certificate

active

08067042

ABSTRACT:
Disclosed herein is a method of using megestrol acetate. In one embodiment, the method comprises informing a user that megestrol acetate is metabolized by a cytochrome p450 isozyme. In another embodiment, the method comprises obtaining megestrol acetate from a container associated with published material providing information is metabolized by a cytochrome p450 isozyme. Also disclosed are articles of manufacture comprising a container containing a dosage form of megestrol acetate, wherein the container is associated with published material informing that megestrol acetate is metabolized by a cytochrome p450 isozyme, a method of treatment, and a method of manufacturing a megestrol acetate product.

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patent: 2003/0108484 (2003-06-01), Leyland-Jones
Zhang et al, Screening study of the inhibitory effects 17 steroides on 6 major cytochrome p450 isoenzymes, Drug metabolism reviews 92006) 38 (3): 99-100.
Kornblith et al, Effect of megestrol acetate on quality of life in a dose-response trial in women with advanced breast cancer, Journal of Clinical Oncology, 11 (11), 1993: 2081-2089.
Williams et al, Crystal structures of human cytochrome P450 3A4 bound to metyrapone and progesterone, Science (New York, N.Y.), (Jul. 30, 2004) vol. 305, No. 5684, pp. 683-686.
Introduction of Megestrol acetate from Wikipedia, accessed on Nov. 13, 2010, pp. 1-2.
Nelson, David R. et al., “P450 Superfamily: Update on New Sequences, Gene Mapping, Accession Numbers and Nomenclature”; Pharmacogenetics; vol. 6; 1996; pp. 1-42.
“Drug Interaction Studies—Study Design, Data Analysis, and Implications for Dosing and Labeling; Preliminary Concept Paper”; Oct. 1, 2004; available @ http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4079B1—04—Topic2-TabA.pdf.

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