RIOMET Metformin Solution Safe, Generics Can Proceed
Published Date: 3/13/2025
Notice
Summary
The FDA has confirmed that RIOMET (metformin hydrochloride) oral solution hasn’t been taken off the market because of safety or effectiveness problems. This means generic versions can keep getting approved as long as they meet the rules. Patients and pharmacies can keep counting on this medicine without any interruptions or extra costs.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Generic approvals for RIOMET can continue
The FDA determined that RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL, has not been withdrawn from sale for reasons of safety or effectiveness. Because of that determination, the Agency will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this product and may continue approving additional ANDAs that refer to it as long as they meet legal and regulatory requirements. RIOMET was originally approved on September 11, 2003, and the sponsor notified FDA that the product was withdrawn from sale as of November 2019; petitions were submitted on March 9, 2023 and December 22, 2023, and the Agency issued its determination on March 7, 2025.
Patients and pharmacies retain access without interruption
You (patients and pharmacies) can continue to rely on RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL, and generic versions may still be approved, which the FDA says avoids interruptions or extra costs. The sponsor reported the product was withdrawn from sale as of November 2019, but FDA reviewed records and literature and determined on March 7, 2025 that the withdrawal was not for safety or effectiveness reasons.
ANDA applicants may need updated labeling
The FDA stated that if it determines that labeling for RIOMET should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. This means generic applicants referencing RIOMET might be asked to update product labeling to comply with current requirements.
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