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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.