The US FDA has issued an approvable letter for prescription MoviPrep (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) of Salix Pharmaceuticals, Ltd.
MoviPrep is currently under review by the Food and Drug Administration for marketing approval as a bowel cleansing agent prior to colonoscopy. Salix licensed exclusive rights to MoviPrep in the United States from Norgine B.V., which has filed a patent application for the drug that, if granted, will provide protection until 2023, stated a release.
"The company was notified that the FDA has completed their review and that the application to market MoviPrep is approvable. Approval is contingent upon the resolution of certain manufacturing deficiencies. Salix is working closely with the product's innovator, Norgine, to resolve these issues in an expeditious manner. Following discussions with the Agency this afternoon, we anticipate a timely resolution to the manufacturing deficiencies and look forward to securing marketing approval very soon and launching the product this year," stated Bill Forbes, Vice President, Research and Development, and Chief Development Officer.
"Norgine has compiled a strong development package which includes two adequate and well-controlled trials that demonstrated the safety and efficacy of MoviPrep for bowel cleansing. MoviPrep is unique among the available purgatives in that it is the only liquid PEG bowel cleansing agent that incorporates ascorbic acid in its formulation which contributes to MoviPrep's efficacy and taste."
Norgine B.V. is a privately-owned, European specialty pharmaceutical company, developing and marketing pharmaceutical products in the therapeutic areas of gastroenterology, hepatology and pain management. Norgine is a leader in this sector in Europe and is unique in having a balanced sales presence across all the major markets.