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Generated: January 21, 2019

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Details for New Drug Application (NDA): 208573

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NDA 208573 describes VENCLEXTA, which is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VENCLEXTA profile page.

The generic ingredient in VENCLEXTA is venetoclax. One supplier is listed for this compound. Additional details are available on the venetoclax profile page.
Summary for 208573
Tradename:VENCLEXTA
Applicant:Abbvie Inc
Ingredient:venetoclax
Patents:2
Generic Entry Opportunity Date for 208573
Generic Entry Date for 208573*:
Constraining patent/regulatory exclusivity:
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: 208573
Mechanism of ActionP-Glycoprotein Inhibitors
Physiological EffectIncreased Cellular Death
Suppliers and Packaging for NDA: 208573
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VENCLEXTA venetoclax TABLET;ORAL 208573 NDA AbbVie Inc. 0074-0561 0074-0561-11 1 BLISTER PACK in 1 CARTON (0074-0561-11) > 2 TABLET, FILM COATED in 1 BLISTER PACK
VENCLEXTA venetoclax TABLET;ORAL 208573 NDA AbbVie Inc. 0074-0561 0074-0561-14 1 BLISTER PACK in 1 CARTON (0074-0561-14) > 14 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 11, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 8, 2025
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Regulatory Exclusivity Expiration:Nov 21, 2025
Regulatory Exclusivity Use:INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
Regulatory Exclusivity Expiration:Jun 8, 2021
Regulatory Exclusivity Use:INFORMATION ADDED TO THE PACKAGE INSERT REGARDING THE REVISION OF THE MONOTHERAPY INDICATION OF VENETOCLAX

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