The Flaxil Label (A, B, C)

Author: Barron, Gregory
Source: Harvard Business School Publishing
Year: 2008
Number of pages: 10 (A), 3 (B), 4 (C)

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Abstract:

These cases focus on the 2001 negotiation between Mytex Pharmaceuticals and the U.S. Food and Drug Administration (FDA). The outcome of the negotiation would determine the new label for Mytex's blockbuster drug for arthritis, Flaxil. The negotiation is quite qualitative and differs from the typical price negotiation with which students are familiar. However, at stake was $500 million in Flaxil sales and the safety of millions of patients. The (A) case presents the perspective of Mytex and the FDA on new data suggesting the Flaxil may have a side effect.