FDA Approves New Salix Product Exclusively In Catalent's Zydis(R) Fast Dissolve Technology

Main Category: Acid Reflux / GERD
Also Included In: Regulatory Affairs / Drug Approvals;  GastroIntestinal / Gastroenterology
Article Date: 04 Nov 2009 - 18:00 PST

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Catalent Pharma Solutions, one of the leading advanced drug delivery technology providers to the pharmaceutical industry, announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Metozolv™ ODT (orally disintegrating tablets) metoclopramide HCL utilizing Catalent's Zydis® fast dissolve technology. Metozolv™ ODT was developed by Wilmington Pharmaceuticals and licensed to Salix Pharmaceuticals. Metozolv™ ODT is the first orally disintegrating tablet formulation for both acute and recurrent diabetic gastroparesis and for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy.

Carolyn Logan, President and CEO of Salix, commented that, "Zydis® fast dissolve was selected for Metozolv™ ODT because this innovative formulation of metoclopramide can be taken without water but still disperse rapidly in the oral cavity, potentially making it more convenient for patients to comply with their medication schedules."

"We are very proud to achieve the FDA approval of Metozolv™ ODT," said Eugene T. Haley, CEO of Wilmington Pharmaceuticals. "We're especially pleased that the application of Catalent's Zydis® technology to this proven medication may enhance the lives of patients for years to come. Metozolv's success further validates the commercial attractiveness of fast dissolving dosage forms and illustrates the significant inherent value in bringing together a game-changing drug delivery technology with product development expertise and a top notch sales and marketing organization."

"The launch of Metozolv™ ODT exclusively in a Zydis® fast dissolve tablet once again demonstrates its ability to deliver unique patient benefits, and we are pleased to collaborate with Wilmington and Salix on this exciting launch," said Ian Muir, Vice President and General Manager of Catalent's Modified Release Technologies business.

Source
Catalent