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Merck Receives FDA Approval For ISENTRESS® (raltegravir) For Pediatric Oral Suspension

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (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 four 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 four 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 four 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 four 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 United States during the third quarter of 2014.

Important Selected Safety Information

ISENTRESS does not cure HIV-1 infection or AIDS.

Severe, potentially life-threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction and toxic epidermal necrolysis. Immediately discontinue treatment with ISENTRESS (raltegravir) and other suspect agents if severe hypersensitivity, severe rash, or rash with systemic symptoms or liver aminotransferase elevations develop and monitor clinical status, including liver aminotransferases closely.

Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment.

ISENTRESS chewable tablets contain phenylalanine, a component of aspartame, which may be harmful to patients with phenylketonuria.

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