Trials & Filings

Oral Suspension of Merck’s Isentress Approved

Formulation cleared to treat HIV in patients four weeks old

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The FDA has approved Isentress for oral suspension, a pediatric formulation of Merck’s integrase inhibitor. The approval opens up Isentress, 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, according to Merck. The oral suspension may be used in patients as young as four weeks of age, weighing at least 3 k...

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