Warner Chilcott Announces 3-Month Extension of PDUFA Date on Next Generation Actonel Product
ARDEE, Ireland, July 16 /PRNewswire-FirstCall/ -- Warner Chilcott plc (Nasdaq: WCRX ) announced today that it has received a communication from the U.S. Food & Drug Administration (FDA) related to its next generation Actonel® product (risedronate sodium) delayed-release tablets extending the Prescription Drug User Fee Act (PDUFA) date by three months to allow sufficient time to review additional information solicited by the FDA and previously provided by the Company. The new PDUFA date is October 24, 2010.
Warner Chilcott is a leading specialty pharmaceutical company currently focused on the gastroenterology, women's healthcare, dermatology and urology segments of the North American and Western European pharmaceuticals markets. The Company is a fully integrated company with internal resources dedicated to the development, manufacturing and promotion of its products. WCRX-G.
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