Drugs

CorMedix Hit With 2nd Complete Response on DefenCath

FDA has issued CorMedix a second complete response letter on its NDA for DefenCath (taurolidine/heparin catheter lock solution) for use in kidney failure patients receiving chronic hemodialysis through a central venous catheter. The letter said the submission cannot be approved until inspection deficiencies at the company’s contract manufacturing organization and the active pharmaceutical ingredient (heparin) facility are resolved, according to the company, which added that no other deficiencies related to DefenCath were cited.

Early last year, FDA issued a complete response letter on the NDA that also cited concerns at a third-party manufacturing facility (see earlier story). Additionally, the agency’s letter requested a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications, CorMedix said at the time.

CorMedix says the unnamed contract manufacturer is compiling responses and corrective action plans related to the inspectional observations. Meanwhile, CorMedix has entered into an agreement with Alcami Corp., a U.S.-based contract manufacturer that will serve as an alternative manufacturing site for DefenCath. “As part of the technology transfer and validation of the manufacturing process at Alcami, CorMedix will also qualify an alternate source of heparin API from a major U.S. supplier,” it says. CorMedix expects to be able to submit a supplement to its NDA application around the end of the first quarter of 2023.

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