The Food and Drug Administration has approved a new formulation of Pancreaze (pancrelipase; Vivus) Delayed Release Capsules which would allow for an extended shelf life of 36 months.

Pancreaze is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases. The product is indicated for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.

The extended shelf life applies to all Pancreaze dosages. “The approval of this [supplemental New Drug Application] is an important milestone for Vivus and for the patients with EPI we seek to treat,” said John Amos, Chief Executive Officer at Vivus. “It highlights our ability to derive additional value from our marketed products and allows patients to store Pancreaze for longer periods of time, which may help to reduce their out-of-pocket expenses.”

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Vivus worked with their manufacturing partner, Nordmark Arzneimittel GmbH & Co. KG, on the FDA approval, pursuant to the terms of an amended manufacturing agreement announced in June 2019.

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