Drugs

FDA Accepts Otsuka NDA Resubmission for Tolvaptan

FDA has accepted an Otsuka Pharmaceutical Co. NDA resubmission for tolvaptan and its expanded use in treating adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD). The agency rejected an earlier submission in 2013, requesting additional data to further evaluate the product’s safety and efficacy in patients with ADPKD. The drug is currently approved for treating hyponatremia. FDA set a user fee review target date of 4/24/2018.

Tolvaptan is a selective V2 receptor antagonist that blocks the vasopressin-mediated activation of the cyclic adenosine monophosphate pathway that leads to cell proliferation and fluid secretion, according to the company. It is believed to inhibit cyst formation, proliferation and growth.

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