United-Guardian, Inc. announced that it has received FDA approval of its Supplemental New Drug Application to market a new single-dose form of Renacidin (Citric Acid, Glucono delta-Lactone, and Magnesium Carbonate), the company’s proprietary irrigating solution that is used to prevent and dissolve calcifications in indwelling catheters.
The newly-approved drug product will be supplied in a 30ml single-use plastic bottle, and will replace the company’s 500ml glass bottle. The company expects to have the new product available for distribution in March or April 2016.
Ken Globus, president of United-Guardian stated, “We are extremely pleased to finally receive FDA approval to market Renacidin in a more user-friendly bottle. Over the many years that Renacidin has been on the market we have received numerous requests to bring to market a ready-to-use, single-dose unit. The new bottle will enable the user to dispense the product directly into a catheter without having to use a separate syringe. We believe that this new single-dose unit will make the product much easier for both medical professionals and caregivers to use, and are very pleased to finally be able to offer this easier-to-use product to the thousands of patients who depend on it.”
United-Guardian, Inc. is a manufacturer of pharmaceuticals, cosmetic ingredients, personal care and health care products.