Drugs

FDA Denies Otsuka Samsca Petition

FDA has denied an Otsuka 8/23/19 petition asking the agency to declare that its Samsca (tolvaptan) 60 milligram tablets were withdrawn for safety reasons. The petition also asked that FDA not approve any pending ANDA for generic Samsca and suspend and withdraw approval of any ANDA for a generic version of Samsca.

In its response, FDA said the company asked for the determination that Samsca was withdrawn for reasons of safety due to the potential for inappropriate prescribing to patients with autosomal dominant polycystic kidney disease (ADPKD). The agency says it reviewed its 2016 determination that the Samsca tablets were not withdrawn for reasons of safety and there was no need to revisit that determination following agency approval of Otsuka’s Jynarque (tolvaptan) tablets for treating ADPKD.

“When FDA approved Jynarque,” the denial letter says, “the agency was aware of the risks associated with Jynarque and the potential for off-label use of Samsca or a future generic of Samsca for ADPKD…. The agency assessed the risk of Samsca being used off-label to treat ADPKD at the time of Jynarque’s approval. Importantly, this assessment contemplated the introduction of any generic drug products referencing Samsca. We determined that the appropriate risk-mitigation approach was to included a Boxed Warning in Samsca’s labeling explicitly stating Samsca’s contraindication for use in patients with ADPKD. Samsca’s labeling currently contains this Boxed Warning and Contraindication. Your petition presents no evidence to show that changes in use have occurred since the time of the agency’s actions in 2018 such that it would be appropriate for the agency to take new measures at this time.”

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