Content about Gastroenterology

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a new dosage of a drug made by Abbott for treating cystic fibrosis in infants, the drug maker said Tuesday.

Abbott announced the approval of an infant-specific dose of Creon (pancrelipase) delayed-released capsules to treat exocrine pancreatic insufficiency due to cystic fibrosis.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for diarrhea caused by a bacterial infection.

The agency announced the approval of Optimer Pharmaceuticals’ Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea, also known as CDAD.

SILVER SPRING, Md.— The Food and Drug Administration has approved a new treatment for chronic hepatitis C, the agency said Friday.

The FDA announced the approval of Merck’s Victrelis (boceprevir) for patients with the disease. The drug is designed for patients who still have some liver function and have not previously received treatment for chronic hepatitis C infection or have failed previous treatments. The drug is approved for use in combination with the generic drug ribavirin and pegylated interferons, biotech drugs used for treating the disease.

INDIANAPOLIS — The Food and Drug Administration declined to approve a drug made by Eli Lilly for treating a disease of the pancreas that often occurs in patients with cystic fibrosis, Lilly said.

BALTIMORE — Medication adherence among hepatitis C patients may improve when patients take antidepressants, according to a new analysis by pharmacy benefit manager Medco Health Solutions presented Monday at the International Conference on Viral Hepatitis.

NATIONAL HARBOR, Md. — A pill developed by AstraZeneca and Pozen that combines a nonsteroidal anti-inflammatory drug with a proton-pump inhibitor was well-tolerated in patients with osteoarthritis, according to a new study.

AstraZeneca announced results of PN400-304, a 12-month study of Vimovo (naproxen and esomeprazole magnesium) delayed-release tablets in patients with osteoarthritis who need daily treatment with NSAIDs but are at risk of NSAID-related gastric ulcers. Vimovo is designed to reduce pain while reducing gastric ulcer risk.

RALEIGH, N.C. — The Food and Drug Administration declined to approve a drug made by Salix Pharmaceuticals for irritable bowel syndrome, Salix said Tuesday.

The FDA issued a complete response letter to Salix for Xifaxan (rifaximin), a treatment for nonconstipation IBS and IBS-related bloating. Salix said it had anticipated that it would receive the letter based on an understanding that the agency needed more information related to retreatment.

CINCINNATI — Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

HOUSTON — A recent clinical trial involving a new drug formulation incorporating aspirin with soy-derived phosphatidylcholine found that the drug combination significantly can reduce irritation to the stomach and upper gastrointestinal tract.

INDIANAPOLIS — An advisory committee of the Food and Drug Administration voted last week not to recommend approval of a drug from Eli Lilly.

The FDA Gastrointestinal Drugs Advisory Committee said it recommended that additional studies be conducted prior to the FDA's review of liprotamase, a nonporcine pancreatic enzyme replacement therapy, for the treatment of exocrine pancreatic insufficiency. EPI is a disease resulting from cystic fibrosis, removal of the pancreas, chronic pancreatitis and other conditions.

BURLINGTON, Mass. — An investigational treatment for irritable bowel syndrome could become a blockbuster by the end of the decade, according to a report by Decision Resources.

The report, which the healthcare market research firm said it would publish later this month, found that linaclotide — made by Ironwood Pharmaceuticals, Forest Labs, Almirall and Astellas Pharma — would emerge as the market leader for IBS and achieve sales of $1.1 billion in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan by 2019.