Gout

• FDA approval · 2022-10-28
  FDA Approved: NAPROXEN SODIUM — Original Application (Camber Consumer Care Inc)

  FDA approved Naproxen Sodium generic from Camber Consumer Care Inc under an Original Application (ANDA211065).

• FDA approval · 2022-10-06
  FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s Naproxen and Esomeprazole Magnesium as an Original Application (ANDA213699), providing a generic versi…

• FDA approval · 2022-09-06
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (CVS)

  The FDA approved a supplemental application for naproxen sodium sponsored by CVS.

• FDA approval · 2022-08-08
  FDA Approved: ALLOPURINOL — Supplemental Application (Gland Pharma Limited)

  FDA approved a supplemental application from Gland Pharma Limited for Allopurinol, enabling the marketing of a generic Allopurinol product u…

• FDA approval · 2022-08-04
  FDA Approved: ALLOPURINOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for allopurinol submitted by Rising Pharma Holdings, Inc. This action authorizes a post-approval…

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• FDA approval · 2022-07-07
  FDA Approved: KRYSTEXXA — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for KRYSTEXXA (pegloticase) by Horizon Therapeutics USA, Inc., expanding the regulatory authoriz…

• FDA approval · 2022-06-07
  FDA Approved: NAPROXEN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber's naproxen generic original application for Naproxen. This generic NSAID is approved for relief of pain and inflammation…

• FDA approval · 2022-03-28
  FDA Approved: FEBUXOSTAT — Original Application (Solco Healthcare US LLC)

  FDA approved an original abbreviated new drug application for febuxostat submitted by Solco Healthcare US LLC.

• FDA approval · 2022-03-11
  FDA Approved: NAPROXEN — Supplemental Application (Granules India Ltd)

  FDA approved a supplemental application for naproxen sodium granules from Granules India Ltd, resulting in an approved supplemental request …

• FDA approval · 2022-03-10
  FDA Approved: COLCHICINE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an original ANDA for colchicine from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals Inc.), providing a generic version of…

• FDA approval · 2022-03-07
  FDA Approved: ALLOPURINOL — Original Application (Harman Finochem Limited)

  FDA approves the original application for Allopurinol from Harman Finochem Limited.

• FDA approval · 2022-02-17
  FDA Approved: ALOPRIM — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for ALOPRIM (allopurinol) submitted by Mylan Institutional LLC.

• FDA approval · 2022-01-26
  FDA Approved: ALLOPURINOL — Original Application (Gland Pharma Limited)

  FDA approved the original application for allopurinol from Gland Pharma Limited, enabling a generic version in the United States.

• FDA approval · 2022-01-06
  FDA Approved: COLCHICINE — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for a generic colchicine product. This approval recognizes a generic colchi…

• FDA approval · 2021-12-07
  FDA Approved: FEBUXOSTAT — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories, LLC's original application for febuxostat, a generic version of the gout and hyperuricemia medication.

• FDA approval · 2021-08-13
  FDA Approved: COLCHICINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original ANDA for colchicine, authorizing a generic version of the drug.

• FDA approval · 2021-08-12
  FDA Approved: COLCHICINE — Original Application (Par Health USA, LLC)

  FDA approved the original application for colchicine (generic) from Par Health USA, LLC.

• FDA approval · 2021-04-28
  FDA Approved: NAPROXEN — Supplemental Application (Acella Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Naproxen filed by Acella Pharmaceuticals, LLC, updating the product's approval status.

• FDA approval · 2021-04-28
  FDA Approved: INDOMETHACIN — Supplemental Application (XLCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for Indomethacin from XLCare Pharmaceuticals Inc. This approval updates the drug's existing FDA appr…

• FDA approval · 2021-04-26
  FDA Approved: INDOMETHACIN — Supplemental Application (XLCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Indomethacin submitted by XLCare Pharmaceuticals Inc. under ANDA 091240.

• FDA approval · 2020-12-16
  FDA Approved: ALOPRIM — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for ALOPRIM (allopurinol) submitted by Mylan Institutional LLC.

• FDA approval · 2020-12-12
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., resulting in changes to the product labeling. This act…

• FDA approval · 2020-10-28
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add Aleve GelCaps (naproxen sodium) as a new gelcap dosage form for naproxen sodium, expanding th…

• FDA approval · 2020-10-22
  FDA Approved: FEBUXOSTAT — Original Application (DR REDDY'S LABORATORIES LIMITED)

  FDA approved a generic febuxostat product from Dr. Reddy's Laboratories Limited via an Original Application (ANDA).

• FDA approval · 2020-08-28
  FDA Approved: ALOPRIM — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for ALOPRIM (allopurinol) submitted by Mylan Institutional LLC. The action relates to updates in the…