These medicines will offer enhanced treatment of common childhood diseases including:
Asthma: A new generation of inhaled corticosteroid with novel release and distribution properties, for the treatment of asthma. The medicine is only activated when it enters the lungs, reducing potential side effects in the mouth and throat. Asthma is the leading cause of school absenteeism, affecting an estimated 6.3 million American children under the age of 18.
Cancer: A medicine that addresses relapsed pediatric malignancies. It is comprised of a widely used anticancer drug encapsulated in a unique drug-delivery system. Cancer, while rare in children, is the chief cause of death by disease in children between ages 1-14.
Cystic Fibrosis: A potential gene treatment to deliver a functional copy of the mutated gene that plays a role in cystic fibrosis. Cystic fibrosis is a genetic disease affecting approximately 30,000 American children and adults. Each year about 3,200 babies are born with this lung disease.
"A child born today can expect to live an average of 30 years longer than a child born a century ago," said PhRMA President and CEO Alan F. Holmer in a PhRMA press release. "Medicines and vaccines play a large role in lengthening a child’s life expectancy as well as improving the quality of that child’s life. With new medicines and new knowledge about the use of existing treatments for children, children will recover from illnesses more quickly and more children will enjoy childhood and grow into healthy adults."
The Food and Drug Administration's Center for Drug Evaluation and Research (CDER) evaluates all new drugs before they can be sold. The Center makes sure that safe and effective drugs are available to improve the health of consumers. CDER ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks.
A complete list of new drugs most recently approved by CDER can be found at: http://www.fda.gov/cder/approval/index.htm
