USFDA grants mexiletine orphan drug designation to Lupin

08 Jun 2020 Evaluate
Lupin has received Orphan Drug Designation (ODD) from US Food and Drug Administration (USFDA) 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 to relax a contraction of skeletal muscle which originates from a voluntary muscular contraction such as shaking someone’s hand and blinking, or everyday activities such as walking across a street and climbing stairs. Mexiletine reduces myotonia symptoms, resulting in a significant improvement in patient quality-of-life and other functional outcomes.

The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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