Drugs

Vifor Asks FDA Reconsideration of Some Venofer Actions

Vifor has petitioned FDA for reconsideration and a stay of certain actions the agency has taken with respect to Venofer (iron sucrose USP) injection that the company says will undermine the public health and are contrary to law. The 6/25 petition arises from FDA’s 5/26 response to an earlier Vifor petition.

Vifor says it does not challenge the response’s conclusion that the solid oral tablet Velphoro (sucroferric oxyhydroxide) was not entitled to new chemical entity exclusivity. But it does challenge the portions of the response that purport to change the established names and active ingredients of Velphoro and several IV iron products, including Venofer, to “ferric oxyhydroxide.” The petition also challenges the actions the agency has taken to implement the change in the Orange Book and in Drugs@FDA.

“We respectfully request that FDA reconsider its decision to change the established name and redefine the active ingredients of iron-containing complex drugs,” Vifor says. “FDA should maintain the distinct established names and active ingredients of these products, many of which have been settled for decades.”

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

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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