MedPath

Varenicline

Generic Name
Varenicline
Brand Names
Champix, Chantix, Tyrvaya
Drug Type
Small Molecule
Chemical Formula
C13H13N3
CAS Number
249296-44-4
Unique Ingredient Identifier
W6HS99O8ZO

Overview

Varenicline is a prescription medication used to treat smoking addiction. This medication is the first approved nicotinic receptor partial agonist. Specifically, varenicline is a partial agonist of the alpha4/beta2 subtype of the nicotinic acetylcholine receptor. In addition it acts on alpha3/beta4 and weakly on alpha3beta2 and alpha6-containing receptors. A full agonism was displayed on alpha7-receptors. On March 9, 2015, the U.S. Food and Drug Administration warned that Varenicline, in the form of Pfizer Inc's quit-smoking drug, Chantix, has been associated with seizures and that some patients who drink while taking the drug may become aggressive or black out. Pfizer is conducting an additional safety study of the drug, results of which are expected in late 2015. The FDA said it is keeping the black box in place at least until the results of the trial are announced.

Indication

For use as an aid in smoking cessation. Varenicline as a nasal spray is indicated for the symptomatic treatment of dry eye disease.

Associated Conditions

  • Dry Eye Syndrome (DES)

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
American Health Packaging
60687-648
ORAL
1 mg in 1 1
4/5/2024
AVALANCHE PHARMACEUTICAL LLC
82582-485
ORAL
0.5 mg in 1 1
3/19/2024
Golden State Medical Supply, Inc.
51407-755
ORAL
0.5 mg in 1 1
2/21/2024
Ajanta Pharma USA Inc.
27241-174
ORAL
1 mg in 1 1
1/30/2024
Leading Pharma, LLC
69315-403
ORAL
1 mg in 56 1
2/10/2024
A-S Medication Solutions
50090-4482
ORAL
1 mg in 1 1
2/1/2019
Aphena Pharma Solutions - Tennessee, LLC
43353-899
ORAL
1 mg in 1 1
12/18/2017
Zydus Lifesciences Limited
70771-1773
ORAL
0.5 mg in 1 1
9/28/2023
Zydus Pharmaceuticals USA Inc.
70710-1614
ORAL
1 mg in 1 1
2/10/2024
Mylan Pharmaceuticals Inc.
0378-5089
ORAL
0.5 mg in 1 1
4/15/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
9/25/2006

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
Champix Tablet 1mg
SIN13323P
TABLET, FILM COATED
1 mg/tablet
8/1/2007
Champix Tablet Starter Pack
SIN13322P
TABLET, FILM COATED
0.5 mg
8/1/2007
Champix Tablet Starter Pack
SIN13322P
TABLET, FILM COATED
1 mg
8/1/2007

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Varenicline Tartrate Tablets
国药准字H20233180
化学药品
片剂
2/14/2023
Varenicline Tartrate Tablets
国药准字H20233181
化学药品
片剂
2/14/2023
Varenicline Tartrate Tablets
国药准字H20213295
化学药品
片剂
4/20/2021
Varenicline Tartrate Tablets
国药准字H20233137
化学药品
片剂
2/7/2023
Varenicline Tartrate Tablets
国药准字HJ20171221
化学药品
片剂
8/10/2023
Varenicline Tartrate Tablets
国药准字H20223758
化学药品
片剂
10/11/2022
Varenicline Tartrate Tablets
国药准字HJ20171223
化学药品
片剂
8/10/2023
Varenicline Tartrate Tablets
国药准字H20223757
化学药品
片剂
10/11/2022
Varenicline Tartrate Tablets
国药准字H20213294
化学药品
片剂
4/20/2021
Varenicline Tartrate Tablets
国药准字HJ20171222
化学药品
片剂
8/10/2023

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
APO-Varenicline 1 mg varenicline (as tartrate) tablets blister pack
393492
Medicine
A
11/24/2022
Blooms The Chemist Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets composite blister pack
393490
Medicine
A
11/24/2022
Blooms The Chemist Varenicline 1 mg varenicline (as tartrate) tablets blister pack
393493
Medicine
A
11/24/2022
APO-Varenicline 1 mg varenicline (as tartrate) tablets blister pack
211940
Medicine
A
4/3/2014
APOTEX-Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets composite blister pack
211945
Medicine
A
4/3/2014
Chemmart Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets composite blister pack
211946
Medicine
A
4/3/2014
Chemmart Varenicline 1 mg varenicline (as tartrate) tablets blister pack
211939
Medicine
A
4/3/2014
APO-Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets composite blister pack
211947
Medicine
A
4/3/2014
VARENAPIX 1 mg varenicline (as tartrate) tablets blister pack
393497
Medicine
A
11/24/2022
Blooms The Chemist Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets composite blister pack
211935
Medicine
A
4/3/2014

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