Details for New Drug Application (NDA): 207027

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NDA 207027 describes PROMACTA KIT, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the PROMACTA KIT profile page.

The generic ingredient in PROMACTA KIT is eltrombopag olamine. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eltrombopag olamine profile page.

Summary for 207027

Tradename:	PROMACTA KIT
Applicant:	Novartis
Ingredient:	eltrombopag olamine
Patents:	7
Formulation / Manufacturing:	see details

Pharmacology for NDA: 207027

Mechanism of Action	Thrombopoietin Receptor Agonists Organic Anion Transporting Polypeptide 1B1 Inhibitors Breast Cancer Resistance Protein Inhibitors UGT1A1 Inhibitors UGT1A3 Inhibitors UGT1A4 Inhibitors UGT1A6 Inhibitors UGT1A9 Inhibitors UGT2B7 Inhibitors UGT2B15 Inhibitors
Physiological Effect	Increased Megakaryocyte Maturation Increased Platelet Production

Suppliers and Packaging for NDA: 207027

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027	NDA	Novartis Pharmaceuticals Corporation	0078-0697	0078-0697-61	1 CARTON in 1 KIT (0078-0697-61) > 30 PACKET in 1 CARTON (0078-0697-23) > 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0697-19)
PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027	NDA	Novartis Pharmaceuticals Corporation	0078-0972	0078-0972-61	1 CARTON in 1 KIT (0078-0972-61) > 30 PACKET in 1 CARTON (0078-0972-23) > 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0972-19)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 25MG ACID/PACKET
Approval Date:	Aug 24, 2015	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Feb 26, 2022
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	Aug 26, 2021
Regulatory Exclusivity Use:	TREATMENT OF PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
Patent:	Start Trial	Patent Expiration:	May 20, 2023	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 207027

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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