Drugs

FDA Lists 40 Safe ARBs

FDA has released a list of 40 angiontensin II receptor blockers (ARBs) for which the agency has reached the conclusion that they do not contain any known nitrosamine impurities. In a statement linking to the list and other documents, FDA commissioner Scott Gottlieb and CDER director Janet Woodcock say they expect the number of ARBs with no known nitrosamine impurities will increase.

“Our goal is for this information to help healthcare providers as they consider acceptable treatment options for their patients,” they write. “Our assessment takes into consideration testing for impurities conducted by FDA’s laboratories, an evaluation of the manufacturing process used by multiple manufacturers of the active pharmaceutical ingredient found in ARB medicines, as well as other information available to the agency from manufacturers and international regulators. We’ll continue to update this list of nitrosamine-free ARBs as we become aware of additional information and as we progress in our assessment of other ARB medications.”

The statement says the list also includes other products on the market that remain under evaluation. “For these ARBs,” Gottlieb and Woodcock say, “although our overall determination is still pending, at this time nitrosamine impurities either have not been detected or are below the interim acceptable intake limits, and the medications can still be distributed.”

The agency says a letter was sent to manufacturers and applicants informing them about factors that can contribute to the formation of nitrosamine impurities during manufacturing and to reiterate steps they should take to ensure these impurities are not present in any ARB in the future. The letter also emphasizes the possibility of contaminated raw materials, including and especially solvents and catalysts, particularly when the products are reused.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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