Drugs

Unexpected Impurity in Some Valsartan Products

FDA says its latest testing of products with the active pharmaceutical ingredient (API) valsartan shows an additional unexpected impurity in three lots of Torrent Pharmaceuticals’ recalled products. An agency news release says that the second impurity, N-Nitrosodiethylamine (NDEA), is a known animal and suspected human carcinogen.

The release also says that FDA and the European Medicines Agency have learned that Zhejiang Huahai Pharmaceuticals found NDEA in several batches of valsartan API. FDA says it immediately began retesting all valsartan API and products, including both recalled products and those currently marketed in the U.S. for NDEA. It found NDEA in some of Zhejiang’s API and in Torrent lots that were made from Zhejiang API.

“FDA is continuing to test all products that contain valsartan for NDEA and related impurities,” the statement says. “If the agency finds NDEA in products that have not been recalled, FDA will work with companies to ensure all affected products are removed from the market. The agency is also evaluating the risks NDEA in these products poses to patients. FDA expects to complete this risk analysis in the coming days and will continue to provide updates to the public as new information becomes available.”

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