One Year Post-Exclusivity Adverse Event Review: Ertapenem Pediatric Advisory Committee Meeting November 16, 2006. Alan M. Shapiro, MD, PhD, FAAP Medical Officer Pediatrics and Maternal Health Staff Office of New Drugs Center for Drug Evaluation and Research Food and Drug Administration.
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Alan M. Shapiro, MD, PhD, FAAP
Pediatrics and Maternal Health Staff
Office of New Drugs
Center for Drug Evaluation and Research
Food and Drug Administration
Drug: Invanz® (ertapenem)
Therapeutic Category: Anti-infective -carbapenem
Sponsor: Merck and Company, Inc.
Indication: Treatment of complicated intra-abdominal infections, complicated skin and skin structure infections, community acquired pneumonia, complicated urinary tract infections, and acute pelvic infections
Original Market Approval: November 21, 2001
Pediatric Exclusivity Granted: February 11, 2005
Safety and effectiveness of INVANZ in pediatric patients 3 months to 17 years of age are supported by:
1 Premier Informatics Data Extracted 3-22-06