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Food and Drug Administration

Pediatric Advisory Committee

April 11, 2007

Briefing Information


Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

March 19, 2007 Briefing Memo pdf

March 28, 2007 Briefing Memo pdf

Age-dependent manifestations of central anticholinergic effects, FDA, Oxybutynin: Ditropan pdf

Post-Pediatric Exclusivity Postmarketing Adverse Event Review: UPDATE for Fall 2006 Pediatric Advisory Committee meeting, FDA, Oxybutynin pdf

Post-Pediatric Exclusivity Post-marketing Adverse Event Review: Drug Use Data Update Oxybutynin (Ditropan NDAAs 17-577 and 18-211, Ditropan XL; NDA 20-897, Oxytrol; NDA 21-351, multiple oxybutynin immediate release generic products) pdf

Final Draft Label, 2003, Ditropan (oxybutynin chloride) pdf

Label, 2004 Ditropan XL pdf

"Psychotic Disorder Induced by Oxybutynin, Presentation of Two Cases," Murat Gulsun, Murat Pinar, Unal Sabanci, Clin Drug Invest 2006: 26 (10): 603-606 Copyrighted

"Anticholinergic Psychosis in Children: A Case Report," Ghada Hamdan-Allen, MD, Mary Nixon, RN, CNS II, Hosp Community Psychiatry, 1991, Feb; 42(2): 191-193 Copyrighted

Lescol Drug Use Review (pdf) [added 4/10/07]

Post-Pediatric Exclusivity Postmarketing Adverse Event Review Drug: Fluvastatin sodium (Lescol [NDA 20-261], Lescol XL [21-192]) pdf

Executive Summary for Pediatric Supplement, Lescol (fluvastatin sodium) pdf

Lescol Label pdf

Sandostatin Adverse Event Review (pdf) [added 4/10/07]

Sandostatin Injection Label pdf

Sandostatin LAR Depot Label pdf

"Drug Therapy," Alastair J.J. Wood, MD, The New England Journal of Medicine, Jan. 25, 1996, 226-254 Copyrighted

"Necrotising enterocolitis," Patricia W. Lin, Barbara J Stoll, Lancet 2006, 368: 1271-83 Copyrighted

"Somatostatin analog (octreotide) in management of neonatal postoperative chylothorax: Is it safe?," Hadi Mohseni-Bod, MD, MRCPCH; Duncan Macrae, MD, MB ChB, FRCA, FRCPCH; Zdenek Slavik, MD, DM, FRCPCH, Pediatr Crit Care Med 2004, Vol., 5, No. 4, 356-357 Copyrighted

"Somatostatin or octreotide as treatment options for chylothorax in young children: a systematic review," Charles C. Roehr, Andreas Jung, et al, Intensive Care Med (2006) 32:650-657 Copyrighted

ODS Postmarketing Safety Review, One-Year Post-Pediatric Exclusivity, Orlistat (Xenical), NDA 20-766 pdf

Xenical AE Review (pdf) [added 4/10/07]

Xenical Use Review 2007 (pdf) [added 4/10/07]

Xenical (orlistat) Capsules Label (pdf)

Additional Briefing Information

Medical Officer's Review of NDA Efficacy Supplement (pdf)

Consultative Review and Evaluation of Clinical Data (pdf)

Office of Clinical Pharmacology and Biopharmaceutics Review (pdf)

"A regional study of underlying congential diseases in term neonates with necrotizing enterocolitis," S. Bolisetty, et al, Acta Paediatr 89 (200) 1226-30 Copyrighted

"Necrotizing Enterocolitis in Neonates With Congenital Heart Disease: Risk Factors and Outcomes," Doff B. McElhinney, M.D., et al., Copyrighted

Discharge Summary, Medwatch (pdf)

Discharge Summary, Medwatch (pdf)

Discharge Summary, Medwatch (pdf)

"Somatostatin analog (octreotide) in management of neonatal postoperative chylothorax: Is it safe?," Hadi Mohseni-Bod, MD, MRCPCH, et al., Pediatr Crit Care Med (2004) Vol. 5, No. 4 Copyrighted

Clinical Review (pdf)

Page updated: April 10, 2007