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FTC Says Ivax Misconstrues Hatch-Waxman Rules

Law360 (April 8, 2005, 12:00 AM EDT) -- The U.S. Food and Drug Administration should reject Ivax Pharmaceutical Inc.’s "flawed" petition for a 180-day marketing exclusivity period for its generic version of Merck & Co.’s cholesterol-lowering drug Zocor, the Federal Trade Commission argued in a brief filed with the court this week.

Ivax submitted an abbreviated new drug application (ANDA) for generic Zocor in 2000 and was entitled to exclusivity under two of Merck & Co.'s patent claims as mandated by the Hatch-Waxman Act.

Under the Hatch-Waxman Act, Congress afforded the first filer of...
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