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Generated: November 14, 2018

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Details for New Drug Application (NDA): 206995

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NDA 206995 describes IRESSA, which is a drug marketed by Astrazeneca and Astrazeneca Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the IRESSA profile page.

The generic ingredient in IRESSA is gefitinib. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gefitinib profile page.
Summary for 206995
Tradename:IRESSA
Applicant:Astrazeneca Pharms
Ingredient:gefitinib
Patents:0
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 206995
Generic Entry Date for 206995*:
Constraining patent/regulatory exclusivity:
FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 206995
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 206995
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRESSA gefitinib TABLET;ORAL 206995 NDA AstraZeneca Pharmaceuticals LP 0310-0482 0310-0482-30 30 TABLET, COATED in 1 BOTTLE (0310-0482-30)
IRESSA gefitinib TABLET;ORAL 206995 NDA AstraZeneca Pharmaceuticals LP 0310-0482 0310-0482-93 30 TABLET, COATED in 1 BOTTLE (0310-0482-93)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jul 13, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 13, 2022
Regulatory Exclusivity Use:FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
Regulatory Exclusivity Expiration:Jul 13, 2018
Regulatory Exclusivity Use:NEW PRODUCT

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