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news.The FDA has granted orphan drug designation to First Horizon Pharmaceutical's glycopyrrolate which is used to treat chronic moderate to severe drooling in pediatric patients, a condition which often results from cerebral palsy and other neurological disorders.
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The Company currently is conducting clinical trials for this indication. Glycopyrrolate, an anticholinergic agent, also is approved as an adjunctive therapy in the treatment of peptic ulcers.
The FDA orphan drug designation is intended to provide incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the US.
Following FDA approval, the designation provides drug market exclusivity for a period of seven years for a product’s orphan indication. Additional incentives include tax credits related to clinical trial expenses, exemption from the FDA user fee, and FDA assistance in clinical trial design.
“The development of this new formulation of glycopyrrolate by First Horizon, together with this orphan drug designation – the first for the company – are the result of our recently expanded Medical Affairs and Regulatory Group and our increased investment in new product development,” stated Patrick Fourteau, president and CEO of First Horizon.