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Generated: January 21, 2019

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Details for New Drug Application (NDA): 022291

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NDA 022291 describes PROMACTA, which is a drug marketed by Novartis Pharms Corp and is included in two NDAs. It is available from two suppliers. There are fourteen patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PROMACTA profile page.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.
Summary for 022291
Tradename:PROMACTA
Applicant:Novartis Pharms Corp
Ingredient:eltrombopag olamine
Patents:14
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022291
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMACTA eltrombopag olamine TABLET;ORAL 022291 NDA GlaxoSmithKline LLC 0007-4640 0007-4640-13 30 TABLET, FILM COATED in 1 BOTTLE (0007-4640-13)
PROMACTA eltrombopag olamine TABLET;ORAL 022291 NDA GlaxoSmithKline LLC 0007-4641 0007-4641-13 30 TABLET, FILM COATED in 1 BOTTLE (0007-4641-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG ACID
Approval Date:Nov 20, 2008TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 11, 2018
Regulatory Exclusivity Use:DOSING INFORMATION ADDED TO THE LABELING REGARDING PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH ITP
Regulatory Exclusivity Expiration:Jun 11, 2018
Regulatory Exclusivity Use:INCLUSION OF PEDIATRIC PATIENTS AGES 6 YRS AND OLDER FOR THE TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC ITP WHO HAVE HAD AN INSUFFICIENT RESPONSE TO CORTICOSTEROIDS, IMMUNOGLOBULINS, OR SPLENECTOMY.
Regulatory Exclusivity Expiration:Nov 16, 2025
Regulatory Exclusivity Use:INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA

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