Pediatric exclusivity has helped us uncover important new information that will help pediatricians and other prescribers use drugs to treat children more safely and confidently. These studies could potentially involve more than 20,000 children. In less than three years, more than 58 pediatric studies have already been conducted. Reports from these studies have been submitted, and exclusivity granted to 28 drugs. Gastroesophageal reflux disease.
Juvenile rheumatoid arthritis.
Obsessive compulsive disorder. Anesthesia and sedation. We have reviewed the current system of labeling drugs for use by pregnant women and are developing an improved, more comprehensive and clinically meaningful approach. We are consulting with multiple government agencies, medical experts, consumer groups and the pharmaceutical industry to develop this new labeling format. The emergence of drug-resistant bacteria is considered to be a major threat to the public health.