Hanmi’s Hyperinsulinism Medicine Designated as Orphan Drug by U.S. FDA

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Hanmi Pharmaceutical announced that its LAPSGlucagon Analog (HM15136) was designated as an orphan drug by the U.S. Food and Drug Administration on February 1.

The Orphan Drug Designation (ODD) by the U.S. FDA is to facilitate the development and authorization of medicines for rare incurable diseases. The system includes tax incentives and new drug application fee exemption. In addition, the first one authorized in each product category is given exclusive rights valid for seven years starting from the date of approval.

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