FDA Grants Approval Digestive Care’s Pertzye Infant Indication

October 19, 2016

Digestive Care has received FDA approval for an infant-specific dose of Pertzye in a 4,000 USP lipase units capsule.

This administration of Pertzye is for infants 12 months and younger with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.

In order for infants to receive the drug administration, the company has reduced the capsule microsphere size range to 0.8 - 1.4 mm in diameter from the “adult size” microspheric range of 0.8 - 2.2 mm.

The recommended dose of Pertzye for infants is one capsule per 120 mL of formula or breast-feeding; this new indication now allows for drug intake from infancy to adulthood.

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