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VIVUS Receives FDA Approval For Improved Formulation Of PANCREAZE With A 36-Month Shelf Life

VIVUS, Inc. (NASDAQ:VVUS) (“VIVUS”), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for an improved

Benzinga · 02/05/2020 12:31

VIVUS, Inc. (NASDAQ:VVUS) (“VIVUS”), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (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 Nordmark Arzneimittel GmbH & Co. KG, its manufacturing partner for 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 exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.