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Deterring Gaming of the Generic Drug Approval Process by the Use of Citizen Petitions

USA - October 15 2018 The FDA has recently thrown its hat into the debate between brand and generic drug manufacturers about the proper way to compete. Generics often...

Martin B. Pavane, David Reichenberg.

FDA’S Clarification of 180-Day Exclusivity Rules

USA - August 23 2018 On July 13, 2018, the FDA issued a letter to ANDA applicants for buprenorphine and naloxone sublingual film that has application beyond that drug...

Martin B. Pavane.

Sham Litigation in a Hatch-Waxman Action

USA - July 10 2018 The largest award in a litigated FTC antitrust case was just issued. It is a warning to brand pharma to take their Hatch-Waxman case filings seriously...

Martin B. Pavane.