Allergan Demands FDA Retract Generic Restasis Guidance

Law360, New York (August 21, 2013, 1:50 PM EDT) -- With generic competition looming, Allergan Inc. on Monday released a letter decrying the U.S. Food and Drug Administration’s proposal not to require human testing for generic versions of dry-eye medicine Restasis, calling the concept “unnecessary, unjustified and potentially unsafe.”

The California-based drugmaker, whose patent protection for Restasis expires next year, used cutting language to urge a reversal of course, accusing regulators of endangering what it says are 23 million Americans with dry-eye disease by departing from long-established scientific principles.

The crux of Allergan’s argument focused on...
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