Familial Mediterranean Fever
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-03-30FDA Approved: COLCHICINE — Supplemental Application (Dr.Reddys Laboratories, Inc.)
FDA approved a supplemental application for Colchicine submitted by Dr. Reddy's Laboratories, Inc.
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FDA approval · 2019-11-14FDA Approved: COLCHICINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for COLCHICINE from Zydus Lifesciences Limited. This indicates a supplemental approval for this gene…
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FDA approval · 2019-09-16FDA Approved: COLCHICINE — Original Application (Mylan Pharmaceuticals Inc.)
The FDA approved a generic colchicine product from Mylan Pharmaceuticals Inc. under an original ANDA (ANDA209470).
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FDA approval · 2019-09-06FDA Approved: COLCHICINE — Original Application (Dr.Reddys Laboratories, Inc.)
FDA approves Dr. Reddy's Laboratories' original ANDA for colchicine, enabling sale of a generic colchicine product.
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FDA approval · 2019-02-19FDA Approved: COLCHICINE — Original Application (Zydus Lifesciences Limited)
FDA approved an original application for Colchicine from Zydus Lifesciences Limited, enabling a generic version of the drug to reach the mar…
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FDA approval · 2019-02-08FDA 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 · 2018-11-29FDA 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…
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FDA approval · 2018-11-16FDA Approved: MITIGARE — Supplemental Application (Hikma Specialty USA Inc.)
The FDA approved a supplemental application for MITIGARE (colchicine) filed by Hikma Specialty USA Inc.
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CLINICAL_TRIALS trial_result · 2018-04-20Clinical Trial Update: Colchicine Levels in the Serum of FMF (Familial Mediterranean Fever) Patients
This clinical trial update reports on measuring colchicine serum levels in patients with Familial Mediterranean Fever (FMF), including consi…
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CLINICAL_TRIALS withdrawal · 2017-10-11Clinical Trial Update: Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission
This clinical trial update shows that the study on inflammatory proteins in Familial Mediterranean Fever during attacks and during remission…
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FDA approval · 2016-12-22FDA 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…
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CLINICAL_TRIALS trial_result · 2016-11-18Clinical Trial Update: Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF) [Phase 2]
Phase 2 pediatric study evaluating the safety and efficacy of canakinumab in patients with colchicine-resistant or colchicine-intolerant fam…
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CLINICAL_TRIALS withdrawal · 2016-10-07Clinical Trial Update: The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever. [NA]
A clinical trial investigating the effect of probiotics on response to therapy and adverse effects in patients with Familial Mediterranean F…
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FDA approval · 2016-01-25FDA 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…
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FDA approval · 2015-12-17FDA Approved: COLCRYS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for COLCRYS (colchicine) submitted by Takeda Pharmaceuticals America, Inc.
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CLINICAL_TRIALS trial_result · 2015-11-11Clinical Trial Update: The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With FMF [Phase 4]
A Phase 4 clinical trial comparing once-daily versus twice-daily colchicine dosing in pediatric patients with Familial Mediterranean Fever h…
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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…
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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…
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CLINICAL_TRIALS trial_result · 2014-06-26Clinical Trial Update: Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene Mutation [Phase 2]
Phase 2 clinical trial update investigating controlled cessation of colchicine therapy in familial Mediterranean fever patients with a singl…
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CLINICAL_TRIALS research · 2014-03-19Clinical Trial Update: Association Between Basal Proteinuria Levels and Pregnancy Outcomes in Familial Mediterranean Fever
A clinical trial investigating the association between basal proteinuria levels and pregnancy outcomes in women with Familial Mediterranean …
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CLINICAL_TRIALS trial_result · 2013-07-10Clinical Trial Update: Interleukin-1 Trap to Treat Autoinflammatory Diseases [Phase 2]
Phase 2 trial evaluating an Interleukin-1 trap for autoinflammatory diseases completed, with results posted in 2013, including Familial Medi…
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CLINICAL_TRIALS trial_result · 2012-10-31Clinical Trial Update: Rilonacept for Treatment of Familial Mediterranean Fever (FMF) [Phase 2]
Phase 2 trial results evaluating rilonacept for familial Mediterranean fever have been completed with results posted in 2012.
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CLINICAL_TRIALS trial_result · 2012-05-01Clinical Trial Update: Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever [Phase 2]
A phase 2 trial evaluating the efficacy and safety of canakinumab in patients with colchicine-resistant familial Mediterranean fever has com…
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CLINICAL_TRIALS trial_result · 2012-01-10Clinical Trial Update: Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients [Phase 1]
A Phase 1 pharmacokinetics study evaluating colchicine in patients with familial Mediterranean fever has completed.
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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.