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Warner Chilcott Announces 3-Month Extension of PDUFA Date on Next Generation Actonel Product

Fri, 07/16/2010 - 7:36am
Bio-Medicine.Org

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.  

The Company

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.

Forward Looking Statements

This press release contains forward-looking statements, including statements concerning our operations, our economic performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "may," "might," "will," "should," "estimate," "project," "plan," "anticipate," "expect," "intend," "outlook," "believe" and other similar expressions are intended to identify forward-looking statements. Readers ar

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