Allergan urges FDA to revise, replace bioequivalence guidelines for generic drugs

In a letter to the U.S. Food and Drug Administration, Allergan requested that the agency revise and replace bioequivalence draft guidelines issued on June 20. The FDA accepted public comment on the proposed guidelines until Aug. 19.Richard Spivey, Allergan’s senior vice president for global regulatory affairs, objected to a proposal in the draft guidance that in vitro analysis alone may establish the bioequivalence of a generic drug to Allergan’s Restasis (cyclosporine ophthalmic suspension 0.05%).

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Allergan urges FDA to revise, replace bioequivalence guidelines for generic drugs

In a letter to the U.S. Food and Drug Administration, Allergan requested that the agency revise and replace bioequivalence draft guidelines issued on June 20. The FDA accepted public comment on the proposed guidelines until Aug. 19.Richard Spivey, Allergan’s senior vice president for global regulatory affairs, objected to a proposal in the draft guidance that in vitro analysis alone may establish the bioequivalence of a generic drug to Allergan’s Restasis (cyclosporine ophthalmic suspension 0.05%).

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