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Details for New Drug Application (NDA): 207027
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 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.
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 207027
| Tradename: | PROMACTA |
| Applicant: | Novartis Pharms Corp |
| Ingredient: | eltrombopag olamine |
| Patents: | 8 |
| Formulation / Manufacturing: | see details |
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: | 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: | Dec 11, 2018 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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