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FDA Approves Maraviroc Labeling Changes

June 2010

FDA Approves Maraviroc Labeling Changes to Include Dosing Recommendation for Patients with Renal Impairment

The FDA has approved labeling changes for Selzentry (maraviroc) 150 mg and 300 mg tablets to include dosing recommendations for patients with renal impairment, add a contraindication for patients with severe renal impairment or end-stage renal disease, add a warning regarding postural hypotension for renal impaired patients, and add new Pharmacokinetics information related to renal impairment.

To read the FDA notice, click here (Adobe Acrobat).