Cystitis

• CLINICAL_TRIALS trial_result · 2016-01-14
  Clinical Trial Update: Effects of Ketamine on Human Bladders and Its Possible Mechanisms

  A completed clinical trial evaluated the effects of ketamine on the human bladder and explored potential mechanisms behind ketamine-associat…

• FDA approval · 2015-10-02
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Alvogen Inc.)

  The FDA approved a supplemental application for Nitrofurantoin Macrocrystals from Alvogen, expanding the approved formulation.

• CLINICAL_TRIALS withdrawal · 2015-07-27
  Clinical Trial Update: Comparison in the Treatment of Acute Cystitis Using Cephalosporin and Norfloxacin (CECI) [Phase 3]

  Phase 3 trial comparing cephalosporin versus norfloxacin for acute cystitis has been withdrawn.

• FDA approval · 2015-04-17
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for nitrofurantoin macrocrystals filed by Amneal Pharmaceuticals of New York LLC.

• CLINICAL_TRIALS trial_result · 2014-06-05
  Clinical Trial Update: Short Course Nitrofurantoin for Acute Cystitis [Phase 2]

  A Phase 2 trial evaluating a short course of nitrofurantoin for acute cystitis has completed.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2013-11-04
  FDA Approved: NITROFURANTOIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for nitrofurantoin from Rising Pharma Holdings, Inc.

• FDA approval · 2013-09-06
  FDA Approved: NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — Supplemental Application (Alvogen Inc.)

  FDA approves a supplemental application for nitrofurantoin monohydrate/macrocrystalline submitted by Alvogen Inc., providing regulatory acti…

• FDA approval · 2012-11-14
  FDA Approved: NITROFURANTOIN (MACROCRYSTALS) — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Nitrofurantoin (Macrocrystals) from Aurobindo Pharma Limited, enabling continued marketing under…

• FDA approval · 2012-11-14
  FDA Approved: NITROFURANTOIN (MACROCRYSTALS) — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for nitrofurantoin macrocrystals from Aurobindo Pharma Limited, authorizing a generic version of the…

• CLINICAL_TRIALS trial_result · 2012-06-29
  Clinical Trial Update: Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment in Acute Uncomplicated Cystitis

  This document reports a completed clinical trial evaluating how antibiotic treatment for acute uncomplicated cystitis affects urinary sympto…

• FDA approval · 2011-10-12
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Nitrofurantoin macrocrystals from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2011-05-11
  FDA Approved: NITROFURANTOIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original application for nitrofurantoin from Amneal Pharmaceuticals NY LLC, granting marketing approval for this generic pr…

• CLINICAL_TRIALS trial_result · 2011-04-28
  Clinical Trial Update: Cefpodoxime vs Ciprofloxacin for Acute Cystitis [NA]

  A completed clinical trial comparing cefpodoxime to ciprofloxacin for acute cystitis has posted results.

• FDA approval · 2010-10-14
  FDA Approved: NITROFURANTOIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Nitrofurantoin submitted by Rising Pharma Holdings, Inc. The approval involves a supplement …

• CLINICAL_TRIALS research · 2010-03-08
  Clinical Trial Update: Treatment and/or Prevention of Urinary Tract Infections [Phase 1]

  A Phase 1 clinical trial update by Biomedical Development Corporation on treatment and/or prevention of urinary tract infections, including …

• FDA approval · 2008-05-30
  FDA Approved: NITROFURANTOIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for nitrofurantoin from Rising Pharma Holdings, Inc. The action likely updates labeling or indic…

• CLINICAL_TRIALS research · 2008-02-22
  Clinical Trial Update: Postoperative Catheterization After Anterior Colporrhaphy [NA]

  A clinical trial update concerning postoperative catheterization after anterior colporrhaphy, associated with cystocele and cystitis.

• FDA approval · 2008-01-16
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Nitrofurantoin Macrocrystals from Amneal Pharmaceuticals of New York LLC. This update confir…

• CLINICAL_TRIALS trial_result · 2007-11-01
  Clinical Trial Update: The Role of Synbiotics in Reducing Post-Operative Infections in Patients Undergoing Cardiac Surgery: A Pilot Study [Phase 4]

  Phase 4 pilot trial investigating whether synbiotics reduce postoperative infections in patients undergoing cardiac surgery; the study was t…

• CLINICAL_TRIALS trial_result · 2007-09-12
  Clinical Trial Update: Risk Factors for Recurrent Urinary Tract Infection in Children

  This completed clinical trial investigated risk factors for recurrent urinary tract infections in children. Sponsored by Kaunas University o…

• FDA approval · 2007-07-13
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Nitrofurantoin Macrocrystals from Amneal Pharmaceuticals of New York LLC.

• CLINICAL_TRIALS withdrawal · 2007-03-02
  Clinical Trial Update: Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis [Phase 4]

  A Phase 4 clinical trial comparing 3-day versus 7-day nitrofurantoin for uncomplicated cystitis in women has been withdrawn.