Gout
📧 Sign up to get email alerts when something new happens for Gout.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2015-07-17FDA 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 · 2015-05-13FDA Approved: ALOPRIM — Supplemental Application (Mylan Institutional LLC)
The FDA approved a supplemental application for ALOPRIM (allopurinol) submitted by Mylan Institutional LLC, resulting in updated labeling.
-
FDA approval · 2014-11-02FDA Approved: NAPROXEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for Naproxen by Amneal Pharmaceuticals of New York LLC (generic Naproxen).
-
FDA approval · 2014-10-16FDA Approved: INDOCIN — Supplemental Application (Zyla Life Sciences US LLC)
FDA approved a supplemental application for Indocin (indomethacin) submitted by Zyla Life Sciences US LLC.
-
FDA approval · 2014-09-26FDA Approved: MITIGARE — Original Application (Hikma Specialty USA Inc.)
FDA approved the Mitigare brand of colchicine (Hikma Specialty USA Inc.) through an Original Application. This establishes a labeled colchic…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2014-08-14FDA Approved: COLCRYS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approves a supplemental application for COLCRYS (colchicine) submitted by Takeda Pharmaceuticals America, Inc. The supplemental approval…
-
FDA approval · 2013-12-12FDA Approved: ULORIC — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for ULORIC (febuxostat) by Takeda Pharmaceuticals America, Inc.
-
FDA approval · 2013-10-10FDA Approved: KRYSTEXXA — Supplemental Application (Horizon Therapeutics USA, Inc.)
FDA approved a supplemental Biologics License Application for Krystexxa (pegloticase) submitted by Horizon Therapeutics USA, Inc. The action…
-
FDA approval · 2013-05-06FDA Approved: ALLOPURINOL — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's original application for the generic drug allopurinol. Allopurinol is used to treat gout and to lower uric …
-
FDA approval · 2013-02-07FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application to add Aleve GelCaps (naproxen sodium) as a new dosage form for the Aleve product line, expanding th…
-
FDA approval · 2012-11-01FDA Approved: ULORIC — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for ULORIC (febuxostat) from Takeda Pharmaceuticals America, Inc.
-
FDA approval · 2012-09-28FDA Approved: INDOMETHACIN — Original Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' indomethacin as an original ANDA (generic) application, making Indomethacin available as a generic …
-
FDA approval · 2012-06-13FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., updating the product's regulatory approval.
-
FDA approval · 2012-04-16FDA Approved: KRYSTEXXA — Supplemental Application (Horizon Therapeutics USA, Inc.)
FDA approved a supplemental application for KRYSTEXXA (pegloticase) from Horizon Therapeutics USA, Inc.
-
FDA approval · 2012-03-15FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application to add Aleve GelCaps containing naproxen sodium, expanding the approval to include a new dosage form…
-
FDA approval · 2011-11-08FDA Approved: NAPROXEN — Original Application (Aurobindo Pharma Limited)
The FDA approved Aurobindo Pharma Limited's original application for a generic naproxen product. Naproxen is a nonsteroidal anti-inflammator…
-
FDA approval · 2011-09-19FDA Approved: NAPROXEN — Original Application (Cipla USA Inc.)
FDA approves Cipla USA Inc.'s Naproxen under Original Application, making a generic naproxen product available. It is used to relieve pain a…
-
FDA approval · 2011-07-20FDA Approved: COLCRYS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for COLCRYS (colchicine) from Takeda Pharmaceuticals America, Inc.
-
FDA approval · 2011-04-12FDA Approved: INDOMETHACIN — Original Application (XLCare Pharmaceuticals Inc.)
FDA approved the Indomethacin Original Application for XLCare Pharmaceuticals Inc., enabling a generic indomethacin product to reach the mar…
-
FDA approval · 2011-01-28FDA Approved: ULORIC — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for ULORIC (febuxostat) submitted by Takeda Pharmaceuticals America, Inc. This notice indicates …
-
FDA approval · 2010-10-19FDA Approved: KRYSTEXXA — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approves a supplemental application for KRYSTEXXA (pegloticase) submitted by Horizon Therapeutics USA, Inc.
-
FDA approval · 2010-09-14FDA Approved: KRYSTEXXA — Original Application (Horizon Therapeutics USA, Inc.)
FDA approves KRYSTEXXA (pegloticase) under the original Biologics License Application for adults with chronic gout refractory to conventiona…
-
FDA approval · 2010-08-12FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)
The FDA approved a supplemental application for Naproxen Sodium submitted by Bionpharma Inc.
-
FDA approval · 2010-04-29FDA Approved: COLCRYS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Colcrys (colchicine) submitted by Takeda Pharmaceuticals America, Inc.
-
FDA approval · 2009-07-29FDA Approved: COLCRYS — Original Application (Takeda Pharmaceuticals America, Inc.)
FDA's original approval package for COLCRYS (colchicine) from Takeda Pharmaceuticals America, Inc., detailing the initial NDA approval of co…