Feb. 05, 2020: VIVUS, a biopharmaceutical company announced that the U.S.FDA has approved the sNDA for an improved formulation of PANCREAZE® (pancrelipase) Delayed Release Capsules that extends the shelf life to 36 months across all PANCREAZE dosages.
VIVUS worked closely with the Nordmark Arzneimittel GmbH & Co. KG, its manufacturing partner for the PANCREAZE, on the FDA approval pursuant to the terms of the amended contract manufacturing agreement announced in June 2019.
PANCREAZE is indicated for the treatment of the exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.
Approved in 2010, PANCREAZE is a pancreatic enzyme preparation consisting of the pancrelipase, an extract derived from the porcine pancreatic glands, as well as other enzyme classes, including porcine-derived lipases, proteases and the amylases. The pancreatic enzymes in the PANCREAZE act like digestive enzymes physiologically secreted by the pancreas.
About Pancreaze:PANCREAZE is a prescription medicine used in order to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions.
PANCREAZE help your body by using fats, proteins, and sugars from food. PANCREAZE contains a mixture of the digestive enzymes including lipases, proteases, and the amylases from pig pancreas. PANCREAZE is safe and effective in the children when taken as prescribed by the doctor.
About VIVUS: VIVUS is a biopharmaceutical company committed to the progress and commercialization of the innovative therapies that focus on advancing treatments for patients with serious unmet medical needs.
https://fda.einnews.com/pr_news/508957511/vivus-receives-u-s-food-and-drug-administration-approval-for-improved-formulation-of-pancreaze-with-a-36-month-shelf-life
