The US Food and Drug Administration (FDA) has approved Aptalis Pharma's, a global specialty pharmaceutical company focused on gastrointestinal diseases and cystic fibrosis, Ultresa and Viokace.
Ultresa (Pancrelipase) delayed release capsules is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis (CF) or other conditions.
Viokace (Pancrelipase) tablets is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.
Frank Verwiel, MD, president and CEO of Aptalis Pharma, stated, “We are very pleased to be 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. This is an important milestone which reinforces Aptalis' long standing commitment to serving their needs.”
Aptalis looks forward to launching Ultresa and Viokace in the US in the near future.