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United-Guardian enters manufacturing, supply agreement with Smiths Medical

United-Guardian disclosed in a regulatory filing that on November 12 the company entered into a written manufacturing and supply agreement with Smiths Medical ASD, retroactive to November 1, pursuant to which Smiths would supply United with a new single-dose form of Renacidin Irrigation. The agreement provides for United and Smiths to work together to develop the new product and provide sufficient data for United to file a supplement to its currently approved New Drug Application for Renacidin with the Food and Drug Administration. The approval would allow United to market Renacidin in a new single dose sterile 30mL vial that would be manufactured using blow-fill-seal packaging technology. Smith’s obligations under the agreement are contingent upon United obtaining FDA approval to market the new product by March 31, 2015 and United expects to file the application in the first half of 2014, the company stated.