Sciele Pharma files NDA for glycopyrrolate oral solution

Sep 29 2009

Sciele Pharma, Inc., a Shionogi company, today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for glycopyrrolate oral solution to treat chronic, moderate-to-severe drooling in pediatric patients. This condition often results from cerebral palsy as well as from other neurological disorders.

Ed Schutter, President and Chief Operating Officer of Sciele Pharma, said, “We are pleased to announce the filing of this NDA for glycopyrrolate oral solution, which represents further diversification of our pediatric product portfolio. Upon approval, this product may provide a meaningful benefit to pediatric patients, especially children with cerebral palsy, who suffer from chronic, moderate-to-severe drooling.”

Glycopyrrolate oral solution has received orphan drug designation from the FDA. The FDA's orphan drug designation is intended to provide incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the U.S. Following FDA approval, the Orphan Drug Act provides drug market exclusivity for a period of seven years for a product's orphan indication.