Fourth Time’s The Charm? Teva Cites Colloids in Latest Attempt to Convince FDA to Require Clinical Trials for Generic Copaxone
This article was originally published in The Pink Sheet Daily
FDA has rejected three previous citizen petitions from Teva seeking to impose barriers on future generic filers for the MS drug.
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A day after announcing the abrupt resignation of CEO Jeremy Levin, Teva’s management emphasized that the company’s current strategy would continue, including plans for dealing with ongoing pressures from Copaxone’s loss of exclusivity, and under-performance of the European generics businesses. Teva hoped to persuade rattled investors of its steady road to growth.
An appeals court ruling on July 26 favoring a faster route to a generic Copaxone brings to the fore longstanding issues of what its regulatory path might look like and how Teva will cope with the erosion of its top product’s sales.
Federal Circuit finds claims covering Copaxone’s latest expiring patent are invalid; Mylan says it plans to launch its generic of the MS drug in May 2014.