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news.Aptalis Pharma has received FDA approval for Ultresa pancrelipase delayed release capsules and Viokace pancrelipase tablets.
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Ultresa (Pancrelipase) delayed release capsules are indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis (CF) or other conditions.
Viokace (Pancrelipase) tablets are indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.
The company plans to launch the products shortly.
Aptalis president and chief executive officer Frank Verwiel said the company is able to bring Ultresa and Viokace to patients with exocrine pancreatic insufficiency.
"With the FDA’s approval of these products, more options are now available to those patients, their caregivers and their physicians," Verwiel added.