Drugs

Vifor Fresenius Wants Velphoro Exclusivity

Vifor Fresenius is asking FDA to grant five-year new active ingredient exclusivity to its Velphoro (sucroferric oxyhydroxide). A 4/15 petition also asks the agency to stay the acceptance, receipt, filing, review, and approval of any ANDA or 505(b)(2) application referencing Velphoro while it continues to consider the drug’s exclusivity status.

The company notes that FDA has been considering the five-year exclusivity for more than 17 months. “Given the imminent expiration of Velphoro’s three-year exclusivity on 11/27,” the petition says, “Vifor Fresenius will be irreparably harmed if the commissioner fails to act soon. Vifor Fresenius respectfully requests expedited consideration of the stay portion of this petition.”

The petition lists these reasons why Velphoro is entitled to five-year new active ingredient exclusivity under either the agency’s active moiety standard or the Federal Food, Drug, and Cosmetic Act’s active ingredient standard:
Velphoro is a novel iron-based phosphate binder with a different active moiety from previous iron-based products; FDA has agreed that there are significant physiochemical differences between Velphoro’s iron oxyhydroxide active moiety and the iron oxyhydroxides in previously approved products; Velphoro does not contain a previously approved active ingredient; and Velphoro’s physiochemical differences are essential for the desired therapeutic indication, not minor differences that the agency can ignore.

The petition also argues that FDA is not in a position to deal with any ANDA or 505(b)(2) application unless and until it has determined whether such action is lawful by ruling on Velphoro’s five-year exclusivity.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome