Details for New Drug Application (NDA): 217469
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NDA 217469 describes VEVYE, which is a drug marketed by Harrow Eye and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the VEVYE profile page.
The generic ingredient in VEVYE is cyclosporine. There are eighteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
The generic ingredient in VEVYE is cyclosporine. There are eighteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 217469
| Tradename: | VEVYE |
| Applicant: | Harrow Eye |
| Ingredient: | cyclosporine |
| Patents: | 5 |
Pharmacology for NDA: 217469
| Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 217469
Suppliers and Packaging for NDA: 217469
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VEVYE | cyclosporine | SOLUTION;OPHTHALMIC | 217469 | NDA | Harrow Eye, LLC | 82667-900 | 82667-900-02 | 1 BOTTLE, DROPPER in 1 CARTON (82667-900-02) / 2 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 0.1% | ||||
| Approval Date: | May 30, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 30, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Sep 22, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Nov 20, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) | ||||||||
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