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Ryanodex Approval History

FDA Approved: Yes (First approved July 22, 2014)
Brand name: Ryanodex
Generic name: dantrolene
Dosage form: Injectable Suspension
Company: Eagle Pharmaceuticals, Inc.
Treatment for: Malignant Hyperthermia

Ryanodex (dantrolene) is a skeletal muscle relaxant in a concentrated formulation for the treatment of malignant hyperthermia.

Development History and FDA Approval Process for Ryanodex

DateArticle
Jul 23, 2014Approval FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia
Mar 20, 2014NDA for Orphan Drug Ryanodex Accepted By FDA

Further information

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