Gout

• FDA approval · 2018-11-16
  FDA Approved: MITIGARE — Supplemental Application (Hikma Specialty USA Inc.)

  The FDA approved a supplemental application for MITIGARE (colchicine) filed by Hikma Specialty USA Inc.

• FDA approval · 2018-07-25
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved Bayer's supplemental application to add ALEVE GELCAPS (naproxen sodium) as an additional formulation of naproxen products.

• FDA approval · 2018-07-13
  FDA Approved: KRYSTEXXA — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA has approved a supplemental application for KRYSTEXXA (pegloticase) from Horizon Therapeutics USA, Inc.

• FDA approval · 2017-08-22
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for ALEVE GELCAPS (naproxen sodium) by Bayer HealthCare LLC., expanding the product through a supple…

• FDA approval · 2017-08-15
  FDA Approved: ULORIC — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ULORIC (febuxostat) submitted by Takeda Pharmaceuticals America, Inc. The submission status …

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• FDA approval · 2017-08-10
  FDA Approved: KRYSTEXXA — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for KRYSTEXXA (pegloticase) from Horizon Therapeutics USA, Inc. This action grants an update to …

• FDA approval · 2017-06-22
  FDA Approved: INDOMETHACIN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's Indomethacin generic under an Original Application; this entry records the approval status and product details.

• FDA approval · 2017-03-10
  FDA Approved: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)

  FDA approved a supplemental application for Naproxen by Zameer Pharmaceuticals LLC.

• FDA approval · 2017-01-23
  FDA Approved: NAPROXEN — Original Application (Amerisource Bergen)

  FDA approves AmerisourceBergen's original application for naproxen sodium tablets, a generic naproxen product.

• FDA approval · 2016-12-22
  FDA Approved: COLCRYS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for COLCRYS (colchicine) from Takeda Pharmaceuticals America, Inc., indicating changes to its labeli…

• FDA approval · 2016-09-09
  FDA Approved: KRYSTEXXA — Supplemental Application (Horizon Therapeutics USA, Inc.)

  FDA approved a supplemental application for KRYSTEXXA (pegloticase) submitted by Horizon Therapeutics USA, Inc., representing an additional …

• FDA approval · 2016-09-09
  FDA Approved: ALLOPURINOL SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Allopurinol Sodium (generic) from Hikma Pharmaceuticals USA Inc. under an ANDA.

• FDA approval · 2016-07-28
  FDA Approved: ALLOPURINOL — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an original (generic) application for allopurinol from Heritage Pharmaceuticals Inc. (d/b/a Avet Pharmaceuticals Inc.).

• FDA approval · 2016-05-10
  FDA Approved: KRYSTEXXA — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for KRYSTEXXA (pegloticase) submitted by Horizon Therapeutics USA, expanding its approved labeli…

• FDA approval · 2016-05-09
  FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal's supplemental application for INDOMETHACIN, marking an approved modification to the product under an ANDA.

• FDA approval · 2016-05-09
  FDA Approved: INDOMETHACIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for Indomethacin, resulting in updated labeling for the product.

• FDA approval · 2016-05-09
  FDA Approved: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)

  FDA approved a supplemental application for Naproxen submitted by Zameer Pharmaceuticals LLC.

• FDA approval · 2016-04-11
  FDA Approved: KRYSTEXXA — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for KRYSTEXXA (pegloticase) submitted by Horizon Therapeutics USA, Inc.

• FDA approval · 2016-02-25
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application to bring ALEVE GELCAPS (naproxen sodium) to market as a new dosage form from Bayer HealthCare LL…

• FDA approval · 2016-02-12
  FDA Approved: ULORIC — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ULORIC (febuxostat) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2016-01-25
  FDA Approved: COLCRYS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for COLCRYS (colchicine) filed by Takeda Pharmaceuticals America, expanding or updating the drug…

• 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.

• FDA approval · 2015-11-13
  FDA Approved: ALLOPURINOL — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Allopurinol from Actavis Pharma, Inc. (NDA018877).

• FDA approval · 2015-08-24
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Naproxen by Hikma Pharmaceuticals USA Inc., indicating changes to the product's approval.

• FDA approval · 2015-07-30
  FDA Approved: KRYSTEXXA — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for Krystexxa (pegloticase) from Horizon Therapeutics USA, Inc.