Zdrowie i gospodarka · 19/10/2010

FDA Clears BUSPAR Tablets for Sale, Citing Lack of Safety or Efficacy Concerns

The Food and Drug Administration (FDA) has determined that BUSPAR (buspirone hydrochloride) Tablets, 10 milligrams (mg), 15 mg, and 30 mg, were not withdrawn from sale for reasons of safety or effectiveness. This means the FDA will not initiate procedures to withdraw approval of abbreviated new drug applications (ANDAs) for this product, and it will continue to approve ANDAs that meet relevant legal and regulatory requirements.