Behçet Disease

• FDA approval · 2026-02-17
  FDA Approved: COLCHICINE — Original Application (Micro Labs Limited)

  FDA approved the original ANDA for colchicine (Colchicine) from Micro Labs Limited, enabling a generic version of the drug. The approval con…

• FDA approval · 2025-12-23
  FDA Approved: OTEZLA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for OTEZLA (apremilast) from Amgen, Inc. The approval updates the labeling for the product.

• FDA approval · 2024-04-25
  FDA Approved: OTEZLA — Supplemental Application (Amgen, Inc)

  The FDA approved Amgen's supplemental application for OTEZLA (apremilast), resulting in an approved supplemental change to the product label…

• FDA approval · 2019-09-16
  FDA Approved: COLCHICINE — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a generic colchicine product from Mylan Pharmaceuticals Inc. under an original ANDA (ANDA209470).

• FDA approval · 2019-02-08
  FDA Approved: COLCHICINE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories, LLC's original ANDA application for Colchicine, making a generic colchicine product available in the U.S.

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• FDA approval · 2018-11-29
  FDA Approved: COLCHICINE — Original Application (Par Health USA, LLC)

  The FDA approved an original ANDA for colchicine from Par Health USA, LLC, enabling the marketing of a generic colchicine product. This repr…

• FDA approval · 2015-12-21
  FDA Approved: OTEZLA — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for OTEZLA (apremilast) from Amgen that updated its labeling.

• FDA approval · 2015-12-17
  FDA Approved: COLCRYS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for COLCRYS (colchicine) submitted by Takeda Pharmaceuticals America, Inc.