Bacterial Vaginosis

• CLINICAL_TRIALS trial_result · 2009-07-10
  Clinical Trial Update: Safety and Efficacy Study of Lactobacillus Administered Vaginally in Women With Bacterial Vaginosis [Phase 2]

  This document reports the completion of a Phase 2 clinical trial evaluating the safety and efficacy of vaginally administered Lactobacillus …

• CLINICAL_TRIALS trial_result · 2009-07-09
  Clinical Trial Update: The Effects of Cranberry Juice on Bacterial Adhesion [NA]

  This document reports a completed clinical trial examining whether cranberry juice affects bacterial adhesion in individuals with bacterial …

• FDA approval · 2009-06-23
  FDA Approved: METRONIDAZOLE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original application for a generic Metronidazole product.

• CLINICAL_TRIALS trial_result · 2009-04-28
  Clinical Trial Update: Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis [Phase 3]

  This entry reports a Phase 3 clinical trial evaluating the efficacy, tolerability, and safety of a clindamycin and ketoconazole combination …

• FDA approval · 2009-03-13
  FDA Approved: METRONIDAZOLE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the original ANDA from Alembic Pharmaceuticals Limited for a generic metronidazole product.

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• CLINICAL_TRIALS trial_result · 2009-01-30
  Clinical Trial Update: The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients [Phase 2, Phase 3]

  This document discusses Phase 2 and Phase 3 clinical trials evaluating the effect of probiotics on immune status, diarrhea, and bacterial va…

• CLINICAL_TRIALS trial_result · 2009-01-22
  Clinical Trial Update: Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis [Phase 4]

  Phase 4 clinical trial update on Lactoserum (Dermacyd Femina) for preventing recurrence of Bacterial Vaginosis; study sponsored by Sanofi an…

• FDA approval · 2007-12-19
  FDA Approved: METRONIDAZOLE — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approved Cosette Pharmaceuticals' original Abbreviated New Drug Application for metronidazole, enabling a generic version of this antimi…

• CLINICAL_TRIALS trial_result · 2007-10-31
  Clinical Trial Update: Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence [NA]

  A randomized trial to reduce recurrence of bacterial vaginosis has completed, sponsored by the University of Washington.

• FDA approval · 2007-10-25
  FDA Approved: METRONIDAZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for metronidazole (ANDA070027), authorizing changes to the approved product through a supplemen…

• CLINICAL_TRIALS trial_result · 2007-08-10
  Clinical Trial Update: Trial of Male Circumcision: HIV, Sexually Transmitted Disease (STD) and Behavioral Effects in Men, Women and the Community [Phase 3]

  A Phase 3 clinical trial update on the effects of male circumcision on HIV, sexually transmitted infections, and related behaviors in men, w…

• FDA approval · 2007-06-27
  FDA Approved: METRONIDAZOLE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Metronidazole from Chartwell RX, LLC (ANDA number 076522).