In August, the Boston-based drugmaker stopped manufacturing Auryxia due to issues with its manufacturer over converting active pharmaceutical ingredients into finished pills.
On Wednesday, the FDA approved the use of a second manufacturer, allowing Keryx to reinitiate manufacturing processes and supply the drug 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,” said Keryx CEO Greg Madison in a statement.
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