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Last Updated: July 13, 2024

Details for New Drug Application (NDA): 215390


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NDA 215390 describes IGALMI, which is a drug marketed by Bioxcel and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the IGALMI profile page.

The generic ingredient in IGALMI is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for 215390
Tradename:IGALMI
Applicant:Bioxcel
Ingredient:dexmedetomidine hydrochloride
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 215390
Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 215390
Suppliers and Packaging for NDA: 215390
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IGALMI dexmedetomidine hydrochloride FILM;BUCCAL, SUBLINGUAL 215390 NDA BioXcel Therapeutics, Inc. 81092-1120 81092-1120-1 10 POUCH in 1 CARTON (81092-1120-1) / 1 FILM in 1 POUCH (81092-1120-0)
IGALMI dexmedetomidine hydrochloride FILM;BUCCAL, SUBLINGUAL 215390 NDA BioXcel Therapeutics, Inc. 81092-1180 81092-1180-1 10 POUCH in 1 CARTON (81092-1180-1) / 1 FILM in 1 POUCH (81092-1180-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;BUCCAL, SUBLINGUALStrengthEQ 0.12MG BASE
Approval Date:Apr 5, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 5, 2025
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Jun 26, 2039Product Flag?YSubstance Flag?Delist Request?
Patented Use:ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL ADMINISTRATION
Patent:⤷  Sign UpPatent Expiration:Jun 26, 2039Product Flag?YSubstance Flag?Delist Request?

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