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FDA approves two new drugs for pancreatic disorders
SILVER SPRING, Md. — The Food and Drug Administration has approved two new drugs for pancreatic disorders, the agency said Thursday.
The FDA announced the approval of Aptalis Pharma's Ultresa and Viokase, both generically known as pancrelipase. Ultresa is a delayed-release capsule for children and adults with cystic fibrosis, which affects the lungs and other organs, while Viokase is meant for use with a proton-pump inhibitor in adults who can't digest food because of pancreatitis or surgical removal of the pancreas.
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FDA approves Biogen Idec's Avonex Pen, dose titration regimen
WESTON, Mass. — The Food and Drug Administration has approved two separate dosing innovations for multiple sclerosis patients that are being treated with a Biogen Idec drug.
Biogen Idec said the FDA approved Avonex pen, the first single-use, once-weekly intramuscular autoinjector approved for MS, and a dose titration regimen, which gradually escalates the dose of Avonex at treatment initiation. The drug maker said the new offerings are designed to improve the treatment experience.