Merck Receives FDA Approval for Isentress (Raltegravir)

Merck, known as MSD outside the US and Canada, has announced that the US FDA recently approved ISENTRESS for oral suspension — a new pediatric formulation of Merck’s integrase inhibitor. 

With this approval, ISENTRESS is now indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients 4 weeks of age and older. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response. 

The oral suspension may be used in patients as young as 4 weeks of age, weighing at least 3 kg to less than 20 kg. The safety and efficacy of ISENTRESS have not been established in infants less than 4 weeks of age. 

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

“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. 

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