FDA clears Eisai gastroesophageal reflux disease therapy for children
The approval was based on positive data from multicenter, double-blind trial conducted in 127 pediatric patients between one to 11 years of age with GERD. Eisai president and
Swedish Orphan Biovitrum (Sobi) has received a complete response letter from the US Food and Drug Administration (FDA) regarding its biologics licence application for nanoencapsulated sirolimus plus pegadricase (NASP), an investigational therapy intended for adults with uncontrolled gout.
Diphenhydramine Hydrochloride Injection, USP, is an injectable antihistamine effective in adults and pediatric patients excluding infants and neonates. BD executive vice president and chief operating officer William Kozy
The application includes safety and efficacy data of the investigational sublingual dissolvable tablet from Phase III trials including a long-term, multi-season trial. Merck Research Laboratories senior vice president,