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Details for New Drug Application (NDA): 207027

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NDA 207027 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 twenty-two 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 two 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 NDA: 207027

Tradename:
PROMACTA
Applicant:
Novartis Pharms Corp
Ingredient:
eltrombopag olamine
Patents:8
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 25MG ACID/PACKET
Approval Date:Aug 24, 2015TE:RLD:Yes
Patent:7,452,874Patent Expiration:May 24, 2021Product Flag?YSubstance Flag?YDelist Request?
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.


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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