perfluorohexyloctane 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| perfluorinated compounds used as blood substitutes and/or diagnostic agents | 5730 | 133331-77-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Perfluorohexyloctane, a semifluorinated alkane, contains 6 perfluorinated carbon atoms and 8 hydrogenated carbon atoms. Perfluorohexyloctane forms a monolayer at the air-liquid interface of the tear film which can be expected to reduce evaporation. The exact mechanism of action for MIEBO in DED is not known.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 18, 2023 | FDA | BAUSCH AND LOMB INC |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
None
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Dry eye disease | indication | 46152009 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 1.338GM/ML | MIEBO | BAUSCH AND LOMB INC | N216675 | May 18, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 10058615 | Sept. 12, 2033 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
| 1.338GM/ML | MIEBO | BAUSCH AND LOMB INC | N216675 | May 18, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 10369117 | Sept. 12, 2033 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
| 1.338GM/ML | MIEBO | BAUSCH AND LOMB INC | N216675 | May 18, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 10449164 | Sept. 12, 2033 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
| 1.338GM/ML | MIEBO | BAUSCH AND LOMB INC | N216675 | May 18, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 10576154 | Sept. 12, 2033 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
| 1.338GM/ML | MIEBO | BAUSCH AND LOMB INC | N216675 | May 18, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 10507132 | June 21, 2037 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1.338GM/ML | MIEBO | BAUSCH AND LOMB INC | N216675 | May 18, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | May 18, 2028 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| 017820 | NDDF |
| 4042329 | VANDF |
| C0766224 | UMLSCUI |
| 12751 | INN_ID |
| 10477896 | PUBCHEM_CID |
| 2637547 | RXNORM |
| D12604 | KEGG_DRUG |
| 7VYX4ELWQM | UNII |
| 367213 | MMSL |
| 41537 | MMSL |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| MIEBO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-377 | SOLUTION | 1 mg | OPHTHALMIC | NDA | 22 sections |