Business · 21/10/2020

FDA Clears BUTISOL SODIUM Oral Tablets for Sale, Citing Lack of Safety or Effectiveness Concerns

The US Food and Drug Administration (FDA) has made a determination that the specified BUTISOL SODIUM oral tablets, including 15mg, 50mg, and 100mg doses, were not withdrawn from the market due to safety or effectiveness issues, allowing the agency to move forward with approving abbreviated new drug applications (ANDAs) for these products.