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Last Updated: June 14, 2024

Details for New Drug Application (NDA): 022254


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NDA 022254 describes VIMPAT, which is a drug marketed by Ucb Inc and is included in three NDAs. It is available from one supplier. Additional details are available on the VIMPAT profile page.

The generic ingredient in VIMPAT is lacosamide. There are twenty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
Summary for 022254
Tradename:VIMPAT
Applicant:Ucb Inc
Ingredient:lacosamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 022254
Suppliers and Packaging for NDA: 022254
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIMPAT lacosamide SOLUTION;INTRAVENOUS 022254 NDA UCB, Inc. 0131-1810 0131-1810-67 10 VIAL, GLASS in 1 CARTON (0131-1810-67) / 20 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength200MG/20ML (10MG/ML)
Approval Date:Oct 28, 2008TE:APRLD:Yes
Regulatory Exclusivity Expiration:Oct 14, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Apr 28, 2026
Regulatory Exclusivity Use:USE OF ALTERNATE INITIAL DOSING REGIMEN FOR INITIATION OF LACOSAMIDE TREATMENT IN PARTIAL ONSET SEIZURE PATIENTS ≥1 MONTH TO

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