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Shire plc acquired ProAmatine as a part of the acquisition of Roberts Pharma in 1999 and Shire conducted and completed the post marketing trials that the FDA required.
The FDA, however, viewed these trials as inconclusive and required that additional trials be conducted for ProAmatine to maintain its marketing authorisation.
As a result, Shire elected to withdraw the product effective September 30, 2010 and notified the FDA in November 2009 and healthcare professionals earlier this year of this decision. Shire’s withdrawal of the NDA was not related to any concerns regarding the safety of ProAmatine.
