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news.Digestive Care (DCI) has gained FDA approval for its new drug application (NDA) for Pertzye, a pancreatic enzyme product containing bicarbonate-buffered enteric-coated microspheres.
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Pertzye is indicated for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis (CF) or other conditions.
DCI marketed Pertzye formulation for over a decade under the trade name PANCRECARB MS-16.
DCI president and chief scientific officer Tibor Sipos said, "The approval of PERTZYE represents a significant milestone for DCI. This achievement confirms our commitment to the continued development of products vital to the well-being of patients living with chronic diseases."
A multicenter, double-blind, placebo-controlled, crossover study conducted in patients ages eight to 43 years with EPI due to CF evaluated the short-term safety and efficacy of Pertzye.