Bacterial Vaginosis
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2024-04-05Clinical Trial Update: Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth [Phase 4]
Phase 4 clinical trial evaluating a screen-and-treat strategy for vaginal flora abnormalities in pregnant women at high risk of preterm birt…
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FDA approval · 2024-03-18FDA Approved: METRONIDAZOLE VAGINAL GEL — Original Application (Encube Ethicals, Inc.)
The FDA approved an original application for METRONIDAZOLE VAGINAL GEL 1.3% from Encube Ethicals, Inc. This marks approval of a generic vers…
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CLINICAL_TRIALS trial_result · 2024-02-05Clinical Trial Update: Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study [Phase 2, Phase 3]
A pilot study evaluating once-weekly secnidazole granules for suppressive antibacterial therapy to prevent recurrent bacterial vaginosis has…
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CLINICAL_TRIALS trial_result · 2024-01-09Clinical Trial Update: Effect of PreforPro® on Urinary and Vaginal Health [Phase 3]
Phase 3 clinical trial update for PreforPro® evaluating urinary and vaginal health, with conditions including bacterial vaginosis and vagina…
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FDA label_change · 2023-11-22FDA Approved: METRONIDAZOLE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for metronidazole from Prasco Laboratories, indicating an updated labeling/approval for an additiona…
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FDA approval · 2023-11-03FDA Approved: CLINDESSE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)
The FDA approved a supplemental application for CLINDESSE (clindamycin phosphate) filed by Padagis Israel Pharmaceuticals Ltd. The action pe…
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FDA approval · 2023-10-17FDA Approved: METRONIDAZOLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for Metronidazole filed by Sun Pharmaceutical Industries, Inc., updating the drug’s labeling as …
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CLINICAL_TRIALS trial_result · 2023-09-28Clinical Trial Update: Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule [Phase 3]
Phase 3 trial comparing two new formulations to Gynomax XL Ovule for treatment of vaginal infections; the study is completed.
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CLINICAL_TRIALS trial_result · 2023-08-15Clinical Trial Update: Safety and Tolerability of Metronidazole Gel 1.3% [Phase 4]
Phase 4 trial update evaluating safety and tolerability of metronidazole gel 1.3% for vaginal bacterial vaginosis.
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CLINICAL_TRIALS trial_result · 2023-07-06Clinical Trial Update: The Effect of Clindamycin and a Live Biotherapeutic on the Reproductive Outcomes of IVF Patients With Abnormal Vaginal Microbiota [Phase 2]
Phase 2 trial investigating clindamycin and a live biotherapeutic for improving reproductive outcomes in IVF patients with abnormal vaginal …
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FDA approval · 2023-06-16FDA Approved: METRONIDAZOLE VAGINAL GEL, 0.75% — Original Application (Encube Ethicals, Inc.)
FDA approved Encube Ethicals' generic Metronidazole vaginal gel 0.75% (ANDA 215610).
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CLINICAL_TRIALS trial_result · 2023-06-15Clinical Trial Update: A Randomized Controlled Trial of Treatment of Bacterial Vaginosis [Phase 4]
A Phase 4 randomized controlled trial assessing treatment for bacterial vaginosis has been terminated; results have been posted.
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CLINICAL_TRIALS trial_result · 2023-05-22Clinical Trial Update: The ASPIRE Trial - Aiming for Safe Pregnancies by Reducing Malaria and Infections of the Reproductive Tract [Phase 3]
Phase 3 ASPIRE trial completed evaluating strategies to reduce malaria and reproductive tract infections during pregnancy.
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FDA approval · 2023-03-06FDA Approved: XACIATO — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for XACIATO, a clindamycin phosphate vaginal gel from Organon LLC.
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CLINICAL_TRIALS trial_result · 2023-02-22Clinical Trial Update: Suppression Of Bacterial Vaginosis (BV) [SUBVert] [Phase 2]
Phase 2 clinical trial update on suppression of bacterial vaginosis (BV) with results posted.
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CLINICAL_TRIALS trial_result · 2022-05-02Clinical Trial Update: A Pilot Study to Evaluate the Efficacy and Safety of Lactobacillus Species Suppositories on Vaginal Health and pH [Phase 4]
Phase 4 pilot study evaluating Lactobacillus suppositories for vaginal health and pH in bacterial vaginosis.
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CLINICAL_TRIALS trial_result · 2022-04-08Clinical Trial Update: Treatment Comparison of Antibiotics Versus Vaginal Lactic Acid in Non-pregnant Women With Acute Symptomatic Bacterial Vaginosis [Phase 4]
A Phase 4 trial comparing antibiotics to vaginal lactic acid for acute symptomatic bacterial vaginosis in non-pregnant women has completed.
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FDA approval · 2022-03-31FDA Approved: METRONIDAZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for metronidazole from Aurobindo Pharma Limited, indicating a supplemental approval for this generic…
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FDA approval · 2022-03-16FDA Approved: METRONIDAZOLE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for METRONIDAZOLE submitted by Prasco Laboratories.
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FDA approval · 2022-02-25FDA Approved: NUVESSA — Supplemental Application (Exeltis USA, Inc.)
The FDA approved a supplemental application for NUVESSA (metronidazole) from Exeltis USA, Inc.
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FDA approval · 2022-01-26FDA Approved: SOLOSEC — Supplemental Application (Evofem Inc.)
The FDA approved a supplemental application for SoLOSEC (secnidazole) from Evofem Inc., expanding the product's labeling/indication.
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FDA approval · 2021-12-15FDA Approved: METRONIDAZOLE — Supplemental Application (Baxter Healthcare Corporation)
The FDA approved a supplemental application for metronidazole from Baxter Healthcare Corporation.
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FDA approval · 2021-12-15FDA Approved: SOLOSEC — Supplemental Application (Evofem Inc.)
FDA approved a supplemental application for SOLOSEC (secnidazole) submitted by Evofem Inc. The action represents an approved supplemental su…
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FDA approval · 2021-12-07FDA Approved: XACIATO — Original Application (Organon LLC)
FDA approved XACIATO (clindamycin phosphate) from Organon LLC under an Original Application; it is a vaginal antibiotic for the treatment of…
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FDA approval · 2021-12-06FDA Approved: NUVESSA — Supplemental Application (Exeltis USA, Inc.)
The FDA approved a supplemental application for NUVESSA (metronidazole) from Exeltis USA, Inc.