Essential Thrombocythemia

• EMA approval · 2025-11-14
  EMA Authorised: Anagrelide Viatris (previously Anagrelide Mylan) (anagrelide hydrochloride) — Viatris Limited

  The EMA has authorised Viatris' Anagrelide (anagrelide hydrochloride) for the treatment of essential thrombocythemia.

• EMA approval · 2025-11-05
  EMA Authorised: Pegasys (peginterferon alfa-2a) — pharmaand GmbH

  EMA authorised Pegasys (peginterferon alfa-2a) for chronic hepatitis C, chronic hepatitis B, polycythemia vera, and essential thrombocythemi…

• FDA approval · 2024-09-23
  FDA Approved: HYDROXYUREA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for Hydroxyurea, confirming an updated approval for the generic produ…

• FDA approval · 2024-05-09
  FDA Approved: ANAGRELIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for ANAGRELIDE submitted by Chartwell RX, LLC. This concerns a generic version of ANAGRELIDE.

• EMA approval · 2023-02-20
  EMA Authorised: Xagrid (anagrelide) — Takeda Pharmaceuticals International AG Ireland

  Anagrelide (Xagrid) has been authorized by EMA for essential thrombocythemia, with Takeda as the marketing authorization holder.

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• FDA approval · 2021-10-13
  FDA Approved: AGRYLIN — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for AGRYLIN (anagrelide hydrochloride) from Takeda Pharmaceuticals America, Inc. The action covers c…

• FDA approval · 2019-12-31
  FDA Approved: ANAGRELIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for ANAGRELIDE from Chartwell RX, LLC.

• FDA approval · 2018-03-20
  FDA Approved: AGRYLIN — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental NDA for AGRYLIN (anagrelide hydrochloride) by Takeda Pharmaceuticals America, Inc., representing an approved sup…

• FDA approval · 2017-12-18
  FDA Approved: DROXIA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for DROXIA (hydroxyurea) submitted by Waylis Therapeutics LLC.

• FDA approval · 2017-06-30
  FDA Approved: ANAGRELIDE — Original Application (Torrent Pharmaceuticals Limited)

  The FDA approved a generic version of anagrelide under an Original Application submitted by Torrent Pharmaceuticals Limited for the treatmen…

• FDA approval · 2016-03-23
  FDA Approved: DROXIA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for DROXIA (hydroxyurea) filed by Waylis Therapeutics LLC.

• FDA approval · 2015-06-01
  FDA Approved: ANAGRELIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for ANAGRELIDE from Chartwell RX, LLC, supporting the approval of this generic product. The acti…

• FDA approval · 2014-10-30
  FDA Approved: AGRYLIN — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for AGRYLIN (anagrelide hydrochloride) submitted by Takeda Pharmaceuticals America, Inc. This ap…

• FDA approval · 2013-07-17
  FDA Approved: AGRYLIN — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for AGRYLIN (anagrelide hydrochloride) submitted by Takeda Pharmaceuticals America, Inc. The approva…

• FDA approval · 2013-02-13
  FDA Approved: ANAGRELIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for ANAGRELIDE from ANI Pharmaceuticals, Inc., authorizing a generic version of the drug. Anagrelide…

• FDA approval · 2012-11-13
  FDA Approved: ANAGRELIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for ANAGRELIDE (ANDA 076683) submitted by Chartwell RX, LLC. This appears to be a non-substantive ad…

• FDA approval · 2011-11-22
  FDA Approved: AGRYLIN — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for AGRYLIN (anagrelide hydrochloride) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2011-01-31
  FDA Approved: AGRYLIN — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for AGRYLIN (anagrelide hydrochloride) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2010-08-31
  FDA Approved: ANAGRELIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for ANAGRELIDE by ANI Pharmaceuticals, Inc.

• FDA approval · 2010-08-31
  FDA Approved: ANAGRELIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for ANAGRELIDE submitted by Chartwell RX, LLC under ANDA076683. This action completes the supple…

• FDA approval · 2008-06-17
  FDA Approved: AGRYLIN — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for AGRYLIN (anagrelide hydrochloride) submitted by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2006-09-19
  FDA Approved: DROXIA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approves a supplemental application for DROXIA (hydroxyurea) submitted by Waylis Therapeutics LLC.

• FDA approval · 2006-08-15
  FDA Approved: HYDROXYUREA — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for HYDROXYUREA submitted by Endo USA, Inc.