Regulatory UpdatesSep 8, 2026•1 min read

FDA Approves Sorbitol-Mannitol (NDA018316) for Urethral Irrigation

By the PharmaCountry team

The FDA has approved the prescription drug Sorbitol-Mannitol (NDA018316), a urethral irrigation solution containing mannitol and sorbitol, manufactured by ICU Medical Inc.

The U.S. Food and Drug Administration has granted approval for Sorbitol-Mannitol (application number NDA018316). The product is marketed under the brand name Sorbitol-Mannitol and is manufactured by ICU Medical Inc. Sorbitol-Mannitol is supplied as a solution for urethral irrigation, packaged in a plastic container. Each 100 mL contains 540 mg of mannitol and 2.7 g of sorbitol. The dosage form is listed as a solution and the route of administration is urethral. Regulatory filings show a series of manufacturing (CMC) submissions that received approval status (AP) between 1984 and 1991, reflecting the product’s compliance with FDA manufacturing standards.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#FDA #drug approval #Sorbitol-Mannitol #urethral irrigation #prescription #ICU Medical