Author: BEF

A dry powder form of the antibiotic TOBI - TOBI Podhaler (tobramycin inhalation powder) - used to treat lung infections caused by the bacteria Pseudomonas aeruginosa has been approved by the US Food and Drug Administration (FDA). People with CF ages six and older who have Pseudomonas aeruginosa  and...

Digestive Care, Inc. (DCI), announced it has received U.S. Food and Drug Administration (FDA) approval of its new drug application for PERTZYE™, indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. PERTZYE is a unique pancreatic enzyme product containing bicarbonate-buffered...

Source: FDA news release Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), were approved March 1 by the U.S. Food and Drug Administration. Ultresa is a delayed-release capsule used to treat children and adults with cystic fibrosis, a serious...

Source: Gilead website February 15, 2012   Important Information Regarding the Availability of Cayston® To the CF Community, Gilead Sciences, Inc., the manufacturer of Cayston, is facing significant and unanticipated challenges manufacturing enough Cayston to meet demand in the United States. Gilead is committed to patient care. To that end, we...

Source: Vertex Pharmaceuticals press release Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has approved KALYDECO™ (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), a rare, genetic disease. KALYDECO (kuh-LYE-deh-koh) is approved for people with CF ages...