FDA Actions

FDA Actions

Rifaximin, Salix Pharmaceutical's minimally absorbed (nonsystemic) oral antibiotic has been approved to reduce the risk of recurrent hepatic encephalopathy in patients with advanced liver disease. Rifaximin was previously approved to treat traveler's diarrhea. The drug, which is taken orally twice a day, appears to reduce ammonia levels by reducing gut flora. It is marketed as Xifaxan^®.

The FDA has approved Pancreaze, a new pancreatic enzyme product for patients who do not produce enough pancreatic enzymes (due to cystic fibrosis, chronic pancreatitis, pancreatic surgery, etc.). Pancreaze is the third approved pancreatic enzyme product on the market after Abbott's Creon^® and Eurand's Zenpep^®. The approval coincides with the FDA's deadline to cease marketing unapproved pancreatic enzyme products that have been available for many years. In October 2007, the FDA announced a deadline of April 28, 2010, after which time unapproved products would no longer be available.

The FDA has approved the first generic version of the popular antihypertensive losartan (Cozaar^®) as well as the combination of losartan and hydrochlorothiazide (Hyzaar^®). This represents the first generic angiotensin receptor blocker on the market, a development that has been anxiously awaited by consumers. Losartan carries a boxed warning against using the drug during pregnancy. Generic losartan is available in 25 mg, 50 mg, and 100 mg strengths, while losartan/hydrochlorothiazide is available in 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg strengths.