Novartis suffers another setback for Prexige debut

Article Abstract:

Novartis AG is postponing the launch of its Prexige painkilling drug after the US Food and Drug Administration requested additional data. The FDA wants more data on the drug's effectiveness and safety.

Author: Greil, Anita
Switzerland, United States. Food and Drug Administration

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Novartis AG

Article Abstract:

The US Food and Drug Administration has told Novartis AG that information had to be added to its Zometa drug's label before its approval can be expanded. Zometa is designed to treat cancer.

Labeling, Zometa (Medication)

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Novartis AG

Article Abstract:

Novartis AG's Prexige painkiller drug has been approved in the United Kingdom. The approval shows that Novartis may launch the drug worldwide in 2004.

United Kingdom, Medicinal and Botanical Manufacturing, Medicinals and botanicals, Analgesics & Antipyretics NEC, Analgesics

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Subjects list: United States, Pharmaceutical industry, Product information, Novartis AG, NVTSY, Prexige (Medication)
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