FDA Approves Sorbitol 3% Irrigation Solution (NDA017863)

The U.S. Food and Drug Administration has approved Sorbitol 3% in a plastic container as an irrigation solution, identified by application number NDA017863. The product is manufactured by Baxter Healthcare Corporation. The approved product is listed under the brand name Sorbitol and the generic name Sorbitol. It is a prescription human drug intended for irrigation (route: IRRIGATION) and is supplied as a solution. The active ingredient is sorbitol at a strength of 3 g per 100 mL. The approval follows a series of FDA submissions. Manufacturing (CMC) submissions were filed on 21 Oct 1981 (submission 8), 8 Dec 1993 (submission 36), 18 Feb 1994 (submission 38), and 14 Aug 2001 (submission 44). Labeling submissions were filed on 31 Jan 1986 (submission 26), 8 May 1991 (submission 34), 23 Mar 2004 (submission 42) and 3 Jul 2002 (submission 40). The most recent labeling letter was dated 28 Mar 2004. This approval expands Baxter Healthcare's portfolio of prescription irrigation products available to healthcare providers.