Prescription medicine
Oteseconazole Brand names: Vivjoa
Oteseconazole (Vivjoa) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the oteseconazole FDA label on DailyMed (effective January 8, 2026, Mycovia Pharmaceuticals, Inc.); the NDA 215888 record on Drugs@FDA; every oteseconazole label on DailyMed.
Highlights of the record
FDA label of January 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVIVJOA™ is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.
Forms and strengths
- 150 mg
Capsule.
On the market
- Earliest approval on file
- April 26, 2022 Vivjoa, Mycovia Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 17, 2036 Vivjoa capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 41 through July 30, 2026
What is oteseconazole used for?
From the label: indications and usageVIVJOA™ is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. ( 1 ) 1.1 Vulvovaginal Candidiasis VIVJOA is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential [see Warnings and Precautions (5.1), Use in Specific Populations (8.3), and Clinical Studies (14) ]. 1.2 Usage If specimens for fungal culture are obtained prior to therapy, antifungal therapy may be instituted before the results of the cultures are known. […]
FDA pharmacologic class: Azole Antifungal.
Source: FDA drug label (VIVJOA), Mycovia Pharmaceuticals, Inc., effective January 8, 2026 (SPL set e21d5008-800e-4417-927f-14340341865f), via openFDA; the full label on DailyMed
Is there a generic for oteseconazole (Vivjoa)?
No generic oteseconazole is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Vivjoa capsules: the compound patent runs to March 17, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the oteseconazole label say about other medicines?
The oteseconazole label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Rosuvastatin | drug interactions | Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvastatin) may increase the exposure of BCRP substrates (e.g., rosuvastatin), which may increase the risk of adverse reactions associated with these drugs. |
Source: FDA drug label (VIVJOA), Mycovia Pharmaceuticals, Inc., effective January 8, 2026 (SPL set e21d5008-800e-4417-927f-14340341865f), via openFDA; the full label on DailyMed
What do FAERS reports show for oteseconazole?
The FDA Adverse Event Reporting System holds 41 reports that list oteseconazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other azole antifungals
- the pharmacologic class, with prices and generics
- Oteseconazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other