FDA panel votes to return MS drug Tysabri to market

Article Abstract:

The blockbuster multiple sclerosis drug Tysabri is back on the market with the approval of the United States Food and Drug Administration with restrictions. Patients using the medication are required to be tracked by law to monitor for side effects. Three cases of multifocal leukoencephalopathy or PML brought reexamination of the medication by the Food and Drug Administration.

United States, Government domestic functions, Drug therapy, Multiple sclerosis, Health policy, Tysabri (Medication)

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Sanofi withdraws obesity-drug application in U.S

Article Abstract:

Sanofi S.A. has withdrawn its U.S. application for its anti-obesity drug to prevent an outright rejection by the Food and Drug Administration, but plans to resubmit it at a later date. Sanofi anticipates sales for the drug, known by the brand names Zimulti and Acomplia, to reach sales of $1 bil per year, but selling the drug in the U.S. is critical to attaining that goal.

Strategy & planning, Planning, Sanofi S.A., United States. Food and Drug Administration, Company business planning

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'Miracle' obesity pill looks less miraculous: repeated FDA delays, European restrictions ail Sanofi's Acomplia

Article Abstract:

Acomplia, the anti-obesity drug introduced by Sanofi-Aventis S.A., has not yet been approved in the United States, and some European countries have concerns about the drug's efficacy. Side effects including anxiety and depression are causing concern for regulators, and the U.S. Food and Drug Administration has refused approval of the drug as a smoking cessation aid.

Complications and side effects, Acomplia (Medication), SNY, Sanofi-Aventis S.A.

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