Drug – bio-affecting and body treating compositions – Solid synthetic organic polymer as designated organic active... – Monomer contains oxygen
Reexamination Certificate
2011-06-21
2011-06-21
Wax, Robert A (Department: 1615)
Drug, bio-affecting and body treating compositions
Solid synthetic organic polymer as designated organic active...
Monomer contains oxygen
C424S078350, C424S501000, C528S398000
Reexamination Certificate
active
07964182
ABSTRACT:
The present invention discloses pharmaceutical composition comprising phosphate binding polymers such as Sevelamer carbonate substantially free of monovalent anion other than bicarbonate anion. Particularly, monovalent anion content is less than about 0.05% (w/w). Disclosed are compositions comprising wet granulated Sevelamer carbonate free of added metal ions and/or added monovalent anion source.
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“(logo) RENVELA® (Sevelamer Carbonate),” label (downloaded from www.fda.gov/cder/foi/label/2007/022127lbl.pdf) Food and Drug Administration (2007).
Ritz, E., et al., “Role of Sodium Intake in the Progression of Chronic Kidney Disease,” Journal of Renal Nutrition 2009, 19 (1): 61-2, (2009).
Chertow, G.M., et al., “The Effects of Sevelamer and Calcium Acetate on Proxies of Atherosclerotic and Arteriosclerotic vascular disease in hemodialysis patients,” American Journal of Nephrology, 23(5): 307-314 (2003).
Mazzeo, J.R. et al., “A Phosphate Binding Assay for Sevelamer Hydrochloride by Ion Chromatography,” J. Pharm. Biomed. Anal. (1999) 19, pp. 911-915.
“(logo) RENEGAL Tablets (sevelamer hydrochloride) 400 and 800 mg,” Package insert (downloaded from http://www.fda.gov/cder/foi/label/2000/21179lbl.pdf), Food and Drug Administration (2000).
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Bhide Yogesh Sharad
Choudhary Varsha Shashank
Omray Ashok
Pharmaceutical Patent Attorneys, LLC
Sasan Aradhana
USV, Ltd
Wax Robert A
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