Eurand NV has received approval from the FDA for its New Drug Application (NDA) for ZENPEP (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions. ZENPEP is the only FDA-approved pancreatic enzyme product (PEP) that has been evaluated in clinical studies in adults and children aged one to 12 years. The drug will be available in four dosage strengths to meet the varied needs of infants, toddlers, adolescents and adults with EPI.

Mylan Pharmaceuticals has received approval from the FDA for its abbreviated new drug application (NDA) for liothyronine sodium tablets USP. The drug will be available in the strengths of 5mcg, 25mcg and 50mcg. Liothyronine sodium tablets are the generic version of King Pharmaceuticals’s treatment for thyroid deficiency, Cytomel. The company has started the shipping of the product.