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 [...]
Zug, Switzerland, June 3 (Korea Bizwire) - Lupin is pleased to announce that it has entered into distribution agreements with three companies for its orphan drug NaMuscla® (mexiletine). Exeltis Healthcare S.L, Cresco Pharma B.V and Macure Pharma ApS will commercialize NaMuscula® for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders in certain [...]
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® [...]
ZUG, Switzerland, Oct. 19 (Korea Bizwire) - Lupin Neurosciences, a specialty pharma division of Lupin Ltd, today announces that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization of NaMuscla™ (mexiletine hydrochloride) for the symptomatic treatment of myotonia [...]