Zdrowie i gospodarka · 28/12/2010

FDA Clears TRANDATE Tablets for Sale, Citing Lack of Safety or Effectiveness Concerns

The Food and Drug Administration (FDA) has determined that TRANDATE (Labetalol Hydrochloride) tablets, 300 milligrams and 400 milligrams, were not withdrawn from sale for reasons of safety or effectiveness. This decision means that the FDA will not initiate procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow the FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.