Drugs

Vifor Asks FDA to Reverse Some Venofer Actions

Vifor says it strongly disagrees with portions of an FDA 5/26/21 response to a 4/19/16 citizen petition in which the company sought new chemical entity exclusivity for its Velphoro (sucroferric oxyhydroxide). In an 8/3 petition, the company says that by the time of FDA’s response, the exclusivity request had become moot through the passage of time and the relevant statutory provisions had been amended by the Encouraging Innovation Act.

It says FDA did not base its response on mootness or the changes in the law and also did not look only at the exclusivity issue or even only to Velphoro. Rather, it redefined the active ingredient for both Velphoro and three complex IV iron products, including Venofer (iron sucrose), and said that all four drugs should be given the same established name.

“Even though the drugs differ in nearly every meaningful way,” Vifor says, “FDA determined that they should all be known and marketed as ‘ferric oxyhydroxide.’ What is more disturbing is that FDA immediately implemented the name change in the Orange Book and on Drugs@FDA.”

Vifor says it strongly disputes those portions of the FDA petition response that purport to change the established names and active ingredients of Velphoro and the other products. It asks that FDA:

withdraw all portions of the response that purport to change the established name and redefine the active ingredients of iron-containing complex drugs, including Venofer;
indefinitely stay its decision to change the established name and redefine the active ingredients of iron-containing complex drugs, maintaining the distinct established names and active ingredients of the products;
refrain from taking any further action to implement the changes described in the petition response, including any action to change the product label or labeling for Venofer, any action to modify the existing product-specific guidance for Venofer or iron sucrose, or any action to change the established name of Venofer to ferric oxyhydroxide; and
give Vifor advance notice and an opportunity to be heard before contacting any naming authority regarding Venofer or iron sucrose.

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