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US FDA Grants Mexiletine Orphan Drug Designation

US FDA Grants Mexiletine Orphan Drug Designation

Zug, Switzerland, June 8 (Korea Bizwire) - Lupin is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to mexiletine hydrochloride for the treatment of myotonic disorders. Myotonic disorders are a group of heterogeneous, inherited, neuromuscular disorders characterized by a shared symptom called myotonia. Myotonia is an inability [...]

Lupin Limited: Orphan Drug NaMuscla® Receives European Commission Approval for the Treatment of Myotonia in Non-Dystrophic Myotonic Disorders

Lupin Limited: Orphan Drug NaMuscla® Receives European Commission Approval for the Treatment of Myotonia in Non-Dystrophic Myotonic Disorders

Zug, Switzerland, Jan. 8 (Korea Bizwire) - Lupin is pleased to announce that the European Commission (EC) has approved NaMuscla® (mexiletine) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction. NaMuscla® [...]