Drugs

FDA Sets Acceptable NITMA Level for Ritonavir Products

FDA has published a guidance, Emerging Scientific and Technical Information on Ritonavir, that sets an acceptable intake (AI) limit of 26.5 ng/day for a nitrosamine drug substance-related impurity known as NITMA (N-((2-isopropylthiazol-4-yl)methyl)-N-methylnitrous amide that may be present in some finished drug products containing ritonavir. The document says manufacturers and applicants may propose an alternative AI limit based on a safety assessment considering mutagenicity and carcinogenicity. “In the absence of justification to support a higher limit,” FDA says, “we recommend that manufacturers and applicants control NITMA such that exposure does not exceed the recommended AI limit of 26.5 ng/day.”

The agency recommends that manufacturers and applicants test their ritonavir drug products to determine whether they contain NITMA. If NITMA is detected, it says, manufacturers and applicants should perform a root cause investigation to identify the source and take appropriate measures to reduce or prevent the formation of NITMA.

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