FDA New Drug and Biologic Approvals, 2018 Midyear Review

New Indications

Inflammatory Demyelinating Polyneuropathy: Hizentra (immune globulin SC)

New indication for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults as maintenance therapy to prevent relapse of neuromuscular disability and impairment.

Pediatric Multiple Sclerosis: Gilenya (fingolimod)

First drug approved for children with multiple sclerosis.

Pediatric Partial Onset Seizures: Briviact (brivaracetam)

Indication for partial onset seizures expanded to include children aged 4 years or older.

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals, 2018 Midyear Review - Medscape - Aug 01, 2018.