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Horizon Pharma plc Receives European Commission Approval for RAVICTI(R) (glycerol phenylbutyrate) Oral Liquid for the Treatment of Urea Cycle Disorders in Patients Two Months of Age and Older

Pediatric ApprovalHorizon Pharma2015-12-02 09:23 Read   321

Horizon Therapeutics Limited, today announced that the European Commission (EC) has adopted a binding decision to approve RAVICTI® (glycerol phenylbutyrate) Oral Liquid for use as an adjunctive therapy for chronic management of adult and pediatric patients two months of age and older with six subtypes of Urea Cycle Disorders (UCDs).

FDA approves new treatment for rare metabolic disorder

Pediatric ApprovalFDA2015-10-24 16:23 Read   282

Oct 23, 2015, the U.S. Food and Drug Administration approved Strensiq (asfotase alfa) as the first approved treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP). 

Gammaplex® Approved For Use In Pediatric Patients

Pediatric ApprovalBPL2015-10-21 13:46 Read   193

Gammaplex [Immune Globulin Intravenous (Human) 5% Liquid] Approved in Patients  2 years and Older with Primary Immunodeficiencies

FDA extends use of Promacta in young children with rare blood disorder

Pediatric ApprovalPharmacodia.com2015-08-24 00:00 Read   522

The U.S. Food and Drug Administration approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP).

U.S. FDA approved Novartis‘ Promacta for the treatment of ITP in pediatric patients

Pediatric ApprovalPharmacodia.com2015-06-11 00:00 Read   365

On Jun 11,2015, FDA approved the expansion of immunotherapy drug Promacta（eltrombopag）applicable to the pediatric patients of 6 years and above for the treatment of idiopathic thrombocytopenic purpura (ITP) who had an unsufficient response to corticosteroids, immunoglobulins, or splenectomy.