USFDA grants Orphan Drug Designation to Lupin's mexiletine hydrochloride

Lupin announced that the US Food and Drug Administration (U.S. FDA) has granted Orphan Drug Designation (ODD) to mexiletine hydrochloride for the treatment of myotonic disorders.

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.

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