Meropenem Wins New FDA Pediatric Indication

New FDA-approved labeling for the antibiotic meropenem adds another pediatric indication to the drug’s portfolio, this time for treating complicated intra-abdominal infections in children younger than three months old.

Meropenem already carries multiple indications for children older than three months, including treating skin infections, bacterial meningitis and intra-abdominal infections.

Until recently, though, the drug’s labeling lacked adequate information on dosing, pharmacokinetic, tolerability and safety data in newborns and young infants with complicated intra-abdominal infections, the FDA says in a summary review of the drug’s pediatric use evidence.

The drug has commonly been used off-label on children under three months of age — especially in premature babies whose organs aren’t yet at full strength, says Anne Zajicek, chief of obstetric and pediatric pharmacology at the National Institute of Child Health and Human Development.

However, this the first time this antibiotic has been officially applied to children that age, and the dosing reflects that, she says. The amount and frequency of dosing varies based on the child’s exact gestational or postnatal age.

The FDA commissioned pediatric studies from Duke and Stanford Universities in August 2005, after NDA holder AstraZeneca declined requests to conduct them. A final report showed that 98 percent of the 200 infants enrolled were alive, with negative bacterial cultures, at day 28 of the study, or three weeks after ending a seven-day course of treatment with meropenem.

Read the summary review at www.fdanews.com/05-27-15-meropenemFRnotice.pdf. The new label is at www.fdanews.com/05-27-15-Meropenemlabel.pdf. — Lena Freund