FDA Clears New Formulation of Raltegravir for Infants

Megan Brooks


January 09, 2014

The US Food and Drug Administration (FDA) has approved the HIV medication raltegravir (Isentress, Merck) for pediatric oral suspension, the company announced today.

"The oral suspension may be used in patients as young as four weeks of age, weighing at least 3 kg to less than 20 kg," the company said in a statement.

Raltegravir belongs to a drug class called HIV integrase strand transfer inhibitors that slow the spread of HIV in the body. "The use of other active agents with Isentress is associated with a greater likelihood of treatment response," the company notes.

"We are very pleased that Isentress can now be a part of a treatment regimen for HIV-1 infected infants and children as young as 4 weeks of age," said Hedy Teppler, executive director, Clinical Research, Merck Research Laboratories, in the news release.

The company notes that the safety and efficacy of the drug have not been established in infants younger than 4 weeks of age.

Formulations of raltegravir for specific populations now include oral suspension, chewable tablets, and film-coated tablets.

As reported by Medscape Medical News, in December 2011, the FDA expanded the indication raltegravir beyond adults to include children and adolescents from 2 to 18 years of age.

Merck anticipates that the new oral suspension formulation will be available in the United States during the third quarter of 2014.


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