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Gefitinib

Generic Name
Gefitinib
Brand Names
Iressa, Gefitinib Mylan
Drug Type
Small Molecule
Chemical Formula
C22H24ClFN4O3
CAS Number
184475-35-2
Unique Ingredient Identifier
S65743JHBS

Overview

Gefitinib (originally coded ZD1839) is a drug used in the treatment of certain types of cancer. Acting in a similar manner to erlotinib (marketed as Tarceva), gefitinib selectively targets the mutant proteins in malignant cells. It is marketed by AstraZeneca under the trade name Iressa.

Background

Gefitinib (originally coded ZD1839) is a drug used in the treatment of certain types of cancer. Acting in a similar manner to erlotinib (marketed as Tarceva), gefitinib selectively targets the mutant proteins in malignant cells. It is marketed by AstraZeneca under the trade name Iressa.

Indication

For the continued treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of either platinum-based or docetaxel chemotherapies.

Associated Conditions

  • Metastatic Non-Small Cell Lung Cancer

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/10/08
Phase 2
Recruiting
2024/09/19
N/A
Recruiting
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
2023/04/28
N/A
Completed
2020/10/05
N/A
UNKNOWN
2020/06/11
Phase 2
UNKNOWN
2020/04/24
Phase 2
UNKNOWN
Second Affiliated Hospital of Nanchang University
2020/01/30
Phase 3
Active, not recruiting
2020/01/27
Phase 3
UNKNOWN
2019/11/27
N/A
Completed
2019/10/29
Phase 3
Active, not recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Qilu Pharmaceutical Co., Ltd.
67184-0531
ORAL
250 mg in 1 1
2/22/2023
Apotex Corp.
60505-4512
ORAL
250 mg in 1 1
8/20/2023
Natco Pharma USA LLC
69339-168
ORAL
250 mg in 1 1
9/27/2023
AstraZeneca Pharmaceuticals LP
0310-0482
ORAL
250 mg in 1 1
2/28/2023
Teva Pharmaceuticals, Inc.
0480-4053
ORAL
250 mg in 1 1
6/21/2023
Ingenus Pharmaceuticals, LLC
50742-366
ORAL
250 mg in 1 1
4/27/2023

EMA Drug Approvals

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
IRESSA TABLET 250 mg
SIN12300P
TABLET, FILM COATED
250 mg
5/22/2003
GEFTINAT FILM COATED TABLETS 250 MG
SIN16130P
TABLET, FILM COATED
250.00 mg
3/22/2021
INGEFITINIB FILM COATED TABLET 250MG
SIN16055P
TABLET, FILM COATED
250.00 mg
12/4/2020
HOVID GEFITINIB TABLETS 250 MG
SIN15984P
TABLET, FILM COATED
250 mg
8/4/2020
VEIASU FILM-COATED TABLETS 250 MG
SIN16030P
TABLET, FILM COATED
250.00 mg
10/22/2020
GEFITINIB-TEVA FC TABLET 250MG
SIN16722P
TABLET, FILM COATED
250 mg
3/2/2023

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Gefitinib Tablets
国药准字HJ20230142
化学药品
片剂
12/5/2023
Gefitinib Tablets
国药准字H20203219
化学药品
片剂
5/26/2020
Gefitinib Tablets
国药准字H20203215
化学药品
片剂
5/26/2020
Gefitinib Tablets
国药准字H20213551
化学药品
片剂
6/29/2021
Gefitinib Tablets
国药准字HJ20181042
化学药品
片剂
5/6/2022
Gefitinib Tablets
国药准字H20203704
化学药品
片剂
12/25/2020
Gefitinib Tablets
国药准字H20223589
化学药品
片剂
8/10/2022
Gefitinib Tablets
国药准字H20243617
化学药品
片剂
4/24/2024
Gefitinib Tablets
国药准字H20193362
化学药品
片剂
8/7/2024
Gefitinib Tablets
国药准字H20163465
化学药品
片剂
8/31/2021

PPB Drug Approvals

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