AEGiS-Reuters: Glaxo Wins FDA Approval for HIV Combo Drug

Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.

Glaxo Wins FDA Approval for HIV Combo Drug

Reuters NewMedia - Thursday November 16, 2000

LONDON (Reuters) - Pharmaceutical group Glaxo Wellcome Plc. said on Wednesday it had won accelerated approval from the US Food and Drug Administration (FDA) for its Trizivir triple-combination tablet for the treatment of HIV.

The company said the medicine, a triple combination tablet that complements Glaxo's existing wide range of HIV treatments, should be available in pharmacies in the US in December.

"The benefits of Trizivir particularly relate to its potent HIV activity in antiretroviral naive patients and its convenient dosing regime of only one tablet twice a day, with no food and water restrictions," Glaxo said in a statement.

The company said Trizivir was already approved in Mexico and had received a positive opinion from the European Union 's committee for proprietary medicinal products in July.

Glaxo is to complete its merger with SmithKline Beecham Plc. by the end of this year to create GlaxoSmithKline, the world's biggest pharmaceutical group by market share.

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