Source: FDA, National Drug Code (US) Revision Year: 2023
ZAVZPRET (zavegepant) nasal spray contains zavegepant hydrochloride, a calcitonin gene-related peptide receptor antagonist. Zavegepant hydrochloride is described chemically as (R)N(3-(7-methyl-1H-indazol-5-yl)1(4-(1-methylpiperidin-4-yl) piperazin-1-yl)-1-oxopropan-2-yl)4(2-oxo-1,2-dihydroquinolin-3-yl) piperidine-1-carboxamide hydrochloride and its structural formula is:
Its molecular formula is C36H46N8O3․HCl, representing a molecular weight of 675.28 g/mol. Zavegepant free base has a molecular weight of 638.82 g/mol. Zavegepant hydrochloride is a white to off-white powder, freely soluble in water, and has pKa values of 4.8 and 8.8.
Each unit-dose ZAVZPRET device for nasal administration delivers 10 mg of zavegepant (equivalent to 10.6 mg of zavegepant hydrochloride) in a buffered aqueous solution containing dextrose, hydrochloric acid, sodium hydroxide, and succinic acid in water for injection. The solution has a pH of 5.3 to 6.7.
| Dosage Forms and Strengths |
|---|
|
Nasal spray: 10 mg of zavegepant per device. Each unit-dose nasal spray device delivers a single spray containing 10 mg of zavegepant. |
| How Supplied |
|---|
|
ZAVZPRET nasal spray (NDC 0069-3500-01) contains 10 mg zavegepant and is supplied as a ready-to-use, unit-dose disposable device. Each carton contains 6 units (NDC 0069-3500-02) and a Patient Information and Instructions for Use leaflet. Distributed by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001 |
| Drug | Countries | |
|---|---|---|
| ZAVZPRET | United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
