USA – FDA Identifies ARBs Without Impurities

For the first time since the US Food and Drug Administration (FDA) discovered a nitrosamine impurity in angiotensin II receptor blockers (ARBs) last summer, the agency has now identified 40 ARBs and counting that do not contain a nitrosamine impurity.

“Our goal is for this information to help health care providers as they consider acceptable treatment options for their patients,” outgoing FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock said in a joint statement. “Our assessment takes into consideration testing for impurities conducted by the FDA’s laboratories, an evaluation of the manufacturing process used by multiple manufacturers of the active pharmaceutical ingredient (API) found in ARB medicines, as well as other information available to the agency from manufacturers and international regulators.”…