• Regulatory NewsRegulatory News

    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 s...
  • Group Calls for REMS-Like Conditions for Popular Hypertension Drugs

    The public safety advocacy group Public Citizen is calling on the US Food and Drug Administration (FDA) to place additional safety warnings and restrictions on several classes of hypertension drugs due to safety concerns. In a petition sent to FDA Commissioner Margaret Hamburg and Center for Drug Evaluation and Research Director Janet Woodcock on 4 October, Public Citizen said three types of hypertension drugs-angiotensin-converting enzyme (ACE) inhibitors, angiotensin...