New FDA Approvals
These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):
• Nitazoxanide (Alinia) by Romark Laboratories. The FDA has approved nitazoxanide (Alinia) Oral Suspension for treatment of children with diarrhea caused by Cryptosporidium parvum and Giardia lamblia. Nitazoxanide is the first and only drug approved by FDA for treatment of Cryptosporidium, and the first new drug approved for Giardia in more than 40 years. The product will be available in pharmacies in February 2003.
Alinia for Oral Suspension (100 mg/5 mL) will be available in a pleasant-tasting, easy-to-use liquid suspension form. A short, three-day treatment has been approved by the FDA for treating diarrhea caused by Cryptosporidium and Giardia in children ages 12 months to 11 years.
In placebo-controlled clinical studies, the side effects experienced by children receiving Alinia were not significantly different from those receiving a placebo. Safety and effectiveness of Alinia have not been studied in children younger than 12 months of age or older than 11 years of age, or in adults. In addition, safety and effectiveness have not been established in patients with immune deficiencies such as patients with human immunodeficiency virus.
• New indication for rabeprazole sodium (Aciphex) by Eisai and Janssen Pharmaceutica. Rabeprazole sodium (Aciphex), a proton pump inhibitor (PPI) widely prescribed for gastroesophageal reflux disease, is now approved by the FDA as part of the first seven-day treatment for Helicobacter pylori infection. Taken in combination with certain antibiotics, rabeprazole sodium treats H. pylori in up to half the time of current 10- to 14-day treatments.