MGI Pharma Inc. announced on Monday that the Food and DrugAdministration has designated Salagen as an orphan drug forthe treatment of xerostomia (dry mouth) andkeratoconjunctivitis sicca (dry eye) in Sjogren's syndromepatients.
Sjogren's syndrome is a chronic condition in which the functionof the lacrimal glands in the eye and the salivary glands andmucus-secreting tissue in the mouth and throat is decreased. Inthe United States, 55,000 people are diagnosed with thesyndrome each year, according to spokeswoman Lori Weiman.
MGI Pharma (NASDAQ:MOGN) in February submitted a newdrug application to the FDA for Salagen, a form of pilocarpinehydrochloride, as a treatment for radiation-induced dry mouth.The Minneapolis company received orphan designation for thisindication in 1990. The company acquired rights to a patent touse Salagen in a mouthwash formulation in September 1991.
The stock gained 75 cents to $13. -- HG
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