FDA Is Evolving On New Chemical Entity Exclusivity

Law360, New York (March 11, 2014, 10:03 AM EDT) -- Combination drugs are becoming increasingly important in treating chronic diseases such as heart disease, stroke, cancer, diabetes and arthritis, which are some of the most common, costly and preventable of all health problems. Patients living with many of these diseases are often prescribed multiple drugs to be taken on varying schedules, and this is where drug combinations are changing the treatment landscape. By offering multiple drugs in a single dose, fixed-combination drugs can improve patient compliance with treatment regimens and contribute to better patient outcomes.

In recognition of the increasingly important role of fixed-combination products, the U.S. Food and Drug Administration...

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