Hagens Berman served as court-appointed co-lead class counsel of a class of direct purchasers alleging that GlaxoSmithKline intentionally submitted a sham citizen petitions to the U.S. Food and Drug Administration, and actually delayed the approval of generic versions of Flonase. The lawsuit claims that GloxoSmithKline stymied the release of the generic of Flonase, fluticasone propionate, by filing multiple citizen petitions with the FDA shortly before the company’s exclusive marketing rights for Flonase were due to expire.
Days before the FDA was set to approve Roxane's abbreviated new drug application for a generic version of Flonase, GlaxoSmithKline began filing petitions to delay approval of any Abbreviated New Drug Applications (ANDAs) for Flonase until the agency established guidelines to determine the bioequivalency of nasal spray product's alleged abuse of the citizen petition process allowed the company to unlawfully maintain monopoly power and overcharge direct purchasers millions of dollars.
CASE TIMELINE
On Mar. 28, 2013, Hagens Berman moved the Hon. Anita Brody of the U.S. District Court for the Eastern District of Pennsylvania for final approval of a $150 million settlement on behalf of direct purchasers who bought the nasal spray, Flonase, from the defendant, GlaxoSmithKline.
