FDA Determines RIOMET Oral Solution Was Not Withdrawn for Safety or Effectiveness
March 13, 2025
March 13, 2025
WASHINGTON, March 13 (TNSFR) -- The Food and Drug Administration (FDA) has concluded that RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL, was not withdrawn from the market due to safety or effectiveness concerns. This determination ensures that the agency will continue to approve abbreviated new drug applications (ANDAs) referencing this medication, provided they meet all necessary regulatory requirements.
RIOMET, initially approved on September 11, 2003, is a metformin . . .
RIOMET, initially approved on September 11, 2003, is a metformin . . .