Spontaneous Urticaria

• FDA label_change · 2021-04-09
  FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for XOLAIR (omalizumab) filed by Genentech to modify the labeling.

• FDA label_change · 2018-06-27
  FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for levocetirizine dihydrochloride (Glenmark Pharmaceuticals Inc., USA) under the ANDA process, lead…

• FDA label_change · 2016-07-06
  FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for XOLAIR (omalizumab) to update its labeling.

• FDA label_change · 2014-09-26
  FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for XOLAIR (omalizumab) submitted by Genentech, resulting in a label change/indication update for th…

• FDA label_change · 2014-02-14
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

  FDA has received a supplemental application for XYZAL (levocetirizine dihydrochloride) from Chattem, Inc.

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