Availability of Oral Formulations Labeled for Use in Young Children in Serbia, Germany and the USA

Current Pharmaceutical Design
Milica BajceticJohn van den Anker

Abstract

The paucity of marketed drug products that have been adequately studied in infants and children and subsequently, licensed (or labeled) for pediatric use has caused abundant use of off-label and unauthorized products in this patient population. In those instances where insufficient pharmacologic or therapeutic information exists for children, the potential for off-label use of medicines to result in therapeutic misadventure does as well. In the USA, a series of regulatory measures have been introduced since 1997 which have increased both the number and scope of pediatric drug trials and also, fostered the development of ageappropriate drug formulations by pharmaceutical companies. Provisions of these regulations for previously marketed drugs include the potential for a company to be granted 6 months of marketing exclusivity, thereby providing them with a financial incentive. For new drugs being developed that have potential pediatric use, the regulations mandate the inclusion of children in the drug development process. In the EU comparable measures have been very recently (Jan 2007) signed into European law to overcome the therapeutic orphan status of the infants and children of Europe. The aims of this study was to compare th...Continue Reading

Citations

Oct 1, 2017·British Journal of Clinical Pharmacology·Sissel Sundell Haslund-KrogHelle Holst
Jul 15, 2021·Contemporary Clinical Trials Communications·S S Haslund-KrogH Holst

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