Drugs

Lawmakers Want Answers on Takeda Natpara Recall

Several lawmakers have written a letter to FDA acting commissioner Ned Sharpless seeking more information about a recent Takeda Pharmaceuticals recall of its hypoparathyroidism drug Natpara (parathyroid hormone). The letter notes that more than 2,000 need the drug to manage their blood calcium levels. It says several patients who are unable to get the drug have been hospitalized, with more expected due to a shortage caused by the recall.

The letter asks about a Takeda- and FDA-created special use program for those with life-threatening health complications. “Despite initial optimism that this program would be broadly helpful for patients, it appears that the scope of the program is so small that it will only help about 1% of the patients who need Natpara, leaving nearly the entire patient population waiting for a solution,” the lawmakers write.

Their letter asks for information on when the original issue resulting in the recall will be resolved. According to an FDA shortage notice, the recall is related to GMP compliance.

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