What the FDA told Oclassen

Oclassen Pharmaceuticals is preparing a response to a warning letter from the FDA regarding its activities as a sponsor and monitor of clinical trials of fialuridine (FIAU) and its FIAC analog conducted between 1989 and 1992.

The letter continues the fallout from the highly publicized deaths of five hepatitis patients participating in a Phase II trial of the drug conducted by Eli Lilly and Co., which licensed the antiviral drug from Oclassen in 1992.

The San Rafael, Calif.,

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