Drugs

Rockwell Medical NDA for Intravenous Trideric

FDA has accepted a Rockwell Medical NDA an intravenous formulation of Triferic (ferric pyrophosphate citrate) for patients with end-stage renal disease and chronic kidney disease. FDA has set a user fee review target action date of 3/28/2020.

In May, the company launched the first product from its portfolio, dialysate Triferic, that is mixed with liquid bicarbonate to deliver iron to patients via the dialysate. The intravenous Triferic, if approved, would allow dialysis centers to administer Triferic to patients regardless of the mode of bicarbonate delivery being used, Rockwell says.

The submission relies on data developed under an FDA-approved special protocol assessment, in which the agency agreed that an equivalence approach to Triferic delivered via hemodialysate (dialysate Triferic) would be acceptable for review. The company says its equivalence study demonstrated that I.V. Triferic delivers the same quantity of iron to patients as the dialysate Triferic formulation.

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