Drugs

Complete Response Letter for Takeda’s Natpara

FDA has issued a complete response letter for the Takeda Natpara (parathyroid hormone) prior approval supplement submitted in 8/2021 to address the potential for rubber particulate formation that led to a U.S. Natpara recall in 9/2019. The company says FDA indicated it could not approve the supplement in its present form. “We are deeply disappointed to inform the hypoparathyroidism community that Natpara’s commercial return to the U.S. is indefinitely delayed,” the company says.

Takeda says that because there are no FDA-approved treatment alternatives for chronic hypoparathyroidism patients, it intends to provide patients enrolled in the Natpara special use program with continued access to free therapy, under regulatory oversight and the direction of FDA, until a commercial product is available.

The company announced in 9/2019 it was recalling Natapara due to a potential issue relating to rubber particulates originating from the rubber septum of the product’s cartridge. That was followed in 10/2019 by lawmakers contacting then-FDA acting commissioner Ned Sharpless asking for more information about the recall and the special use program, with the lawmakers saying it appeared the program would help only about 1% of the patients who need Natpara.

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