Gaucher Disease Type

• FDA approval · 2024-07-10
  FDA Approved: CEREZYME — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for Cerezyme (imiglucerase) from Genzyme Corporation.

• FDA approval · 2018-08-29
  FDA Approved: CERDELGA — Supplemental Application (Genzyme Corporation)

  The FDA approved a supplemental application for Cerdelga (eliglustat) filed by Genzyme Corporation.

• EMA approval · 2014-11-21
  Cerdelga recommended for approval in type 1 Gaucher disease

  The EMA recommends approval of Cerdelga for type 1 Gaucher disease, indicating regulatory consideration for this indication.

• FDA approval · 2014-11-05
  FDA Approved: CERDELGA — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for Cerdelga (eliglustat) from Genzyme Corporation.

• FDA approval · 2014-08-19
  FDA Approved: CERDELGA — Original Application (Genzyme Corporation)

  FDA approved Cerdelga (eliglustat) from Genzyme Corporation as an oral substrate reduction therapy for adults with Gaucher disease type 1, m…

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• FDA approval · 2014-02-10
  FDA Approved: ZAVESCA — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved a supplemental application for ZAVESCA (miglustat) from Actelion Pharmaceuticals US, Inc., typically indicating an update or ex…