Gaucher Disease

• FDA label_change · 2025-12-22
  FDA Approved: ELELYSO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for ELELYSO (taliglucerase alfa) submitted by Pfizer Laboratories Div Pfizer Inc, resulting in chang…

• FDA label_change · 2015-10-30
  FDA Approved: CEREZYME — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for Cerezyme (imiglucerase) from Genzyme Corporation, resulting in changes to the product labeling.

• FDA label_change · 2015-02-03
  FDA Approved: VPRIV — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for VPRIV (velaglucerase alfa) from Takeda Pharmaceuticals America, Inc., resulting in changes to th…

• FDA label_change · 2014-05-14
  FDA Approved: ELELYSO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for ELELYSO (taliglucerase alfa) filed by Pfizer Laboratories Div Pfizer Inc. The approval resul…

• FDA label_change · 2010-11-23
  FDA Approved: ZAVESCA — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  The FDA approved a supplemental application for ZAVESCA (miglustat) filed by Actelion Pharmaceuticals US, Inc.

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