AEGiS-Reuters: Boehringer's HIV drug gets U.S. nod for pediatics

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Boehringer's HIV drug gets U.S. nod for pediatics

Reuters NewMedia - Monday November 23, 1998

COLUMBUS, Ohio, Nov 23 (Reuters) - Roxane Laboratories, a Boehringer Ingelheim GmbH company, said Monday that it has received clearance from the U.S. Food and Drug Administration to market a pediatric formulation of the AIDS drug Viramune to treat infants and children infected with HIV.

Roxane said that Viramune, the seventh AIDS medication to be cleared by the FDA for use in the treatment of pediatric HIV/AIDS, is a liquid suspension taken twice daily.

Fourteen agents are currently available for adults.

Viramune, which has been available in tablet form since August 1996, was developed by by Boehringer Ingelheim and is marketed in the United States by Roxane Laboratories.

Viramune is the first agent belonging to the class of drugs called NNRTIs, or non-nucleoside reverse transcriptase inhibitors, to be approved for use in children.

Viramune should always be administered in combination with at least one additional antiretroviral agent, Roxane noted.
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