Literature DB >> 23412997

Recent new drug approvals. Part 1: drugs with pediatric indications.

Chasity M Shelton1, Rebecca F Chhim, Michael L Christensen.   

Abstract

This two-part review provides information about drugs that have been recently approved by the Food and Drug Administration and focuses on drugs approved with pediatric indications or approved in adults with active pediatric studies. Information was obtained from the product labeling and selected published studies. Part 1 reviews recently approved drugs with labeled pediatric indications, and Part 2 will review recent drug approvals in adults that have potential use in pediatrics and have active studies.

Keywords:  Food and Drug Administration; drug approval; drug industry; pediatric

Year:  2012        PMID: 23412997      PMCID: PMC3567886          DOI: 10.5863/1551-6776-17.4.329

Source DB:  PubMed          Journal:  J Pediatr Pharmacol Ther        ISSN: 1551-6776


  23 in total

1.  Natural products as insecticides: the biology, biochemistry and quantitative structure-activity relationships of spinosyns and spinosoids.

Authors:  T C Sparks; G D Crouse; G Durst
Journal:  Pest Manag Sci       Date:  2001-10       Impact factor: 4.845

2.  Preliminary definition of improvement in juvenile arthritis.

Authors:  E H Giannini; N Ruperto; A Ravelli; D J Lovell; D T Felson; A Martini
Journal:  Arthritis Rheum       Date:  1997-07

3.  Pharmacokinetics of a F(ab')2 scorpion antivenom in healthy human volunteers.

Authors:  H Vázquez; A Chávez-Haro; W García-Ubbelohde; R Mancilla-Nava; J Paniagua-Solís; A Alagón; C Sevcik
Journal:  Toxicon       Date:  2005-09-28       Impact factor: 3.033

Review 4.  Pharmacokinetic/pharmacodynamic relationships of asparaginase formulations: the past, the present and recommendations for the future.

Authors:  Vassilios I Avramis; Eduard H Panosyan
Journal:  Clin Pharmacokinet       Date:  2005       Impact factor: 6.447

5.  Comparison of Escherichia coli-asparaginase with Erwinia-asparaginase in the treatment of childhood lymphoid malignancies: results of a randomized European Organisation for Research and Treatment of Cancer-Children's Leukemia Group phase 3 trial.

Authors:  Michel Duval; Stefan Suciu; Alina Ferster; Xavier Rialland; Brigitte Nelken; Patrick Lutz; Yves Benoit; Alain Robert; Anne-Marie Manel; Etienne Vilmer; Jacques Otten; Noël Philippe
Journal:  Blood       Date:  2002-04-15       Impact factor: 22.113

6.  Results of the Dana-Farber Cancer Institute ALL Consortium Protocol 95-01 for children with acute lymphoblastic leukemia.

Authors:  Albert Moghrabi; Donna E Levy; Barbara Asselin; Ronald Barr; Luis Clavell; Craig Hurwitz; Yvan Samson; Marshall Schorin; Virginia K Dalton; Steven E Lipshultz; Donna S Neuberg; Richard D Gelber; Harvey J Cohen; Stephen E Sallan; Lewis B Silverman
Journal:  Blood       Date:  2006-09-26       Impact factor: 22.113

7.  Embryonic development of human lice: rearing conditions and susceptibility to spinosad.

Authors:  Gastón Mougabure Cueto; Eduardo Zerba; María Inés Picollo
Journal:  Mem Inst Oswaldo Cruz       Date:  2006-05       Impact factor: 2.743

8.  Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial.

Authors:  Shumpei Yokota; Tomoyuki Imagawa; Masaaki Mori; Takako Miyamae; Yukoh Aihara; Shuji Takei; Naomi Iwata; Hiroaki Umebayashi; Takuji Murata; Mari Miyoshi; Minako Tomiita; Norihiro Nishimoto; Tadamitsu Kishimoto
Journal:  Lancet       Date:  2008-03-22       Impact factor: 79.321

9.  High-dose methotrexate-induced nephrotoxicity in patients with osteosarcoma.

Authors:  Brigitte C Widemann; Frank M Balis; Beate Kempf-Bielack; Stefan Bielack; Charles B Pratt; Stefano Ferrari; Gaetano Bacci; Alan W Craft; Peter C Adamson
Journal:  Cancer       Date:  2004-05-15       Impact factor: 6.860

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