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.
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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