Details for New Drug Application (NDA): 217469
✉ Email this page to a colleague
The generic ingredient in VEVYE is cyclosporine. There are eighteen drug master file entries for this compound. Nineteen 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 | 82667-900-00 | 1 BOTTLE, DROPPER in 1 CARTON (82667-900-00) / 2 mL in 1 BOTTLE, DROPPER |
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: | ⤷ Sign Up | Patent Expiration: | Sep 22, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | 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) |
Complete Access Available with Subscription