The U.S. Food and Drug Administration has approved Keryx Biopharmaceuticals Inc.’s application for a second drug product contract manufacturer. Patheon Manufacturing Services LLC of Greenville, N.C., is now manufacturing Auryxia. Keryx said it has rebuilt supply and will promptly make Auryxia available to wholesalers.
“Getting a second drug product manufacturer approved was an important step to ensuring long-term supply of Auryxia is consistently available to patients,” Greg Madison, president and chief executive officer of Keryx Biopharmaceuticals.
The company announced in August that is was having manufacturing difficulties and had to stop production of Auryxia. Keryx quickly exhausted its reserves and the drug has not been available for prescription until the FDA approved the new manufacturer.