Drugs

FDA Denies Vifor Fresenius Velphoro Petition

FDA has denied a Vifor Fresenius 4/15/16 petition asking the agency to recognize that Velphoro (sucroferric oxyhydroxide) is eligible for five-year new chemical entity (NCE) exclusivity based, among other things, on an assertion that Velphoro does not contain a previously-approved active ingredient. The petition also asked FDA to stay the acceptance, filing, review, and approval of any ANDA or any 505(b)(2) NDA referencing Velphoro until the agency has made its decision on five-year NCE exclusivity.

The 5/26 denial letter says the agency is denying the request for five-year NCE exclusivity because it has concluded that Velphoro’s active moiety and active ingredient is ferric oxyhydroxide, which is in previously approved drugs.

“Velphoro does not contain a new chemical entity and is not eligible for five-year NCE exclusivity,” the letter says. “Furthermore, we conclude that the active ingredient of Velphoro — like its active moiety — is ferric oxyhydroxide and has also been previously approved. Accordingly, we would deny your request for five-year NCE exclusivity even if we were to determine Velphoro’s eligibility for five-year NCE exclusivity based on the active ingredient of the product, as you propose.”

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