Bacterial Vaginosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-10-14FDA Approved: METRONIDAZOLE — Original Application (Solaris Pharma Corporation)
FDA approved Solaris Pharma Corporation's generic metronidazole (METRONIDAZOLE) under an original ANDA.
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FDA approval · 2021-09-03FDA Approved: METRONIDAZOLE — Original Application (Alembic Pharmaceuticals Limited)
FDA approved Alembic Pharmaceuticals Limited's original ANDA for Metronidazole, enabling a generic version of the antibiotic/antiprotozoal.
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FDA approval · 2021-08-19FDA Approved: METRONIDAZOLE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
The FDA approved a supplemental application for METRONIDAZOLE submitted by Unichem Pharmaceuticals (USA), Inc., signaling an approved change…
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FDA approval · 2021-08-18FDA Approved: METRONIDAZOLE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved a supplemental application for Metronidazole from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
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CLINICAL_TRIALS trial_result · 2021-07-09Clinical Trial Update: Probiotics as Adjuvant Treatment for Bacterial Vaginosis [Phase 4]
Phase 4 trial update on probiotics as adjuvant treatment for bacterial vaginosis; results posted after completion.
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CLINICAL_TRIALS trial_result · 2021-07-02Clinical Trial Update: DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE) [Phase 3]
Phase 3 clinical trial update for DARE-BV1 in treating bacterial vaginosis; trial completed and results posted in 2021.
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FDA approval · 2021-06-14FDA Approved: SOLOSEC — Supplemental Application (Evofem Inc.)
The FDA approved a supplemental application for SOLOSEC (secnidazole) submitted by Evofem Inc.
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CLINICAL_TRIALS trial_result · 2021-04-13Clinical Trial Update: A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis [Phase 3]
Phase 3 trial of SYM-1219 for bacterial vaginosis completed; results posted.
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CLINICAL_TRIALS trial_result · 2021-04-13Clinical Trial Update: Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219 [Phase 3]
Open-label Phase 3 trial evaluating a single-dose SYM-1219 for safety in bacterial vaginosis has completed with results posted.
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FDA approval · 2021-03-05FDA Approved: METRONIDAZOLE — Supplemental Application (Baxter Healthcare Corporation)
The FDA approved a supplemental application for Metronidazole submitted by Baxter Healthcare Corporation.
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CLINICAL_TRIALS trial_result · 2021-02-01Clinical Trial Update: Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent Recurrence of Bacterial Vaginosis [Phase 4]
Phase 4 trial update on oral metronidazole with Lactobacillus vaginal suppositories to prevent recurrence of bacterial vaginosis.
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CLINICAL_TRIALS trial_result · 2020-12-19Clinical Trial Update: Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV [Phase 4]
Phase 4 trial update assessing safety of a single 2 g oral dose of Solosec (secnidazole) for adolescent girls with bacterial vaginosis.
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CLINICAL_TRIALS trial_result · 2020-09-16Clinical Trial Update: Safety Study of Lactobacillus Administered Vaginally to Healthy Women [Phase 1]
Phase 1 safety study of vaginally administered Lactobacillus in healthy women completed; results posted.
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FDA approval · 2020-05-26FDA Approved: TINDAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for tinidazole from Rising Pharma Holdings, Inc.
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CLINICAL_TRIALS trial_result · 2020-04-27Clinical Trial Update: Randomized Controlled Trial of Treatment of Male Partners of Women With BV [Phase 3]
Phase 3 randomized trial evaluating treatment of male partners of women with recurrent bacterial vaginosis has completed and results posted.
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CLINICAL_TRIALS trial_result · 2020-04-22Clinical Trial Update: Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis [Phase 2, Phase 3]
A phase 2/phase 3 trial evaluated Trimosan Gel for pessary-associated bacterial vaginosis; study completed with posted results in 2020.
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CLINICAL_TRIALS trial_result · 2020-03-12Clinical Trial Update: The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis [Phase 4]
Phase 4 trial update on norethisterone enanthate for recurrent bacterial vaginosis; completed study.
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CLINICAL_TRIALS trial_result · 2020-02-11Clinical Trial Update: LACTIN-V Study for Recurrent Bacterial Vaginosis [Phase 2]
Phase 2 clinical trial of LACTIN-V for recurrent bacterial vaginosis completed; results posted in 2020.
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CLINICAL_TRIALS trial_result · 2020-01-31Clinical Trial Update: Evaluation of Efficacy and Safety of Gynomax® XL Ovule [Phase 4]
Phase 4 trial evaluating efficacy and safety of Gynomax XL Ovule for vaginal infections has been completed.
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CLINICAL_TRIALS trial_result · 2019-12-26Clinical Trial Update: A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women [Phase 3]
A Phase 3 randomized, double-blind study comparing clindamycin phosphate vaginal cream 2% to Clindesse and to placebo in non-pregnant women …
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CLINICAL_TRIALS trial_result · 2019-11-04Clinical Trial Update: Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections [Phase 4]
Phase 4 trial assessing boric acid with probiotics for vaginal infections including candidiasis and bacterial vaginosis; study completed wit…
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CLINICAL_TRIALS trial_result · 2019-10-14Clinical Trial Update: Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis [Phase 3]
Phase 3 trial evaluating equivalence of GDC-229 to Metronidazole vaginal gel for bacterial vaginosis has completed with results posted.
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CLINICAL_TRIALS research · 2019-09-11Clinical Trial Update: Women's Improvement of Sexual Health (WISH) Demonstration Project
Clinical trial update for the Women's Improvement of Sexual Health (WISH) Demonstration Project, with completed status and posted results.
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FDA approval · 2019-08-14FDA Approved: METRONIDAZOLE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
The FDA approved a supplemental application for Metronidazole from Unichem Pharmaceuticals (USA), Inc., supporting a generic version under A…
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FDA approval · 2019-07-29FDA Approved: METRONIDAZOLE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Metronidazole from Aurobindo Pharma Limited, updating an existing generic product approval.