Aug 25 2010
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiary Shire Pharmaceuticals Inc. received a ruling from the FDA on its Citizen's Petition relating to Pentasa.
The ruling granted-in-part and denied-in-part the requests from Shire. Shire had requested the FDA to issue formal guidance, consistent with the FDA's advice to Shire, requiring that bioequivalence to Pentasa be shown by both rigorous dissolution testing and studies with clinical endpoints. The FDA response to the Shire's Citizen's Petition granted the request with regard to the dissolution testing and denied the request with respect to the studies with clinical endpoints. The FDA response further imposed a requirement for pharmacokinetic data to establish bioequivalence.
A copy of the FDA's ruling can be found in the Investors section of the Company's website: http://www.shire.com.
SOURCE Shire plc