Court Refuses To Reclassify Allergan's Restasis As Non-Antibiotic

Law360, New York (January 23, 2005, 12:00 AM EST) -- The U.S. District Court for the District of Columbia has dismissed a lawsuit by drug maker Allergan, Inc., which sought to overturn the U.S. Food and Drug Administration’s classification of Restasis as an antibiotic devoid of marketing exclusivity rights.

The court ruled that the classification of Restasis (cyclosporine ophthalmic emulsion 0.05%) as an antibiotic is supported by the FDA's Modernization Act of 1997.

Under federal regulations, antibiotics are not entitled to the patent and exclusivity protection otherwise available under the Hatch Waxman amendments to the Food,...
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