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Par Pharmaceutical Companies Reports Adjusted EPS of $0.65 for Fourth Quarter 2009
Date:2/24/2010

an class="xn-chron">November 2009, Par successfully launched the 100mg and 200mg strengths of tramadol ER.  Tramdol ER is the generic version of Ortho-McNeil's Ultram® ER product. Annual U.S. sales of the 100mg and 200mg strengths of Ultram® ER are approximately $150 million, according to IMS Health data.

In February 2010, Strativa Pharmaceuticals announced that due to a FDA foreign travel restriction to India, the FDA has been unable to perform a recent inspection of the clinical and analytical sites for the bioequivalence study related to Zuplenz™.  The NDA cannot be approved until the FDA receives a satisfactory inspection report.  The FDA restriction on foreign travel in India has been subsequently lifted and the inspection of the clinical and analytical sites for the bioequivalence study related to Zuplenz is in the process of being scheduled.  No issues related to the study data or film product were identified.

Par currently has approximately 27 ANDAs pending with the FDA, 12 of which Par believes to be first-to-file opportunities with a brand value of approximately $6.3 billion.

Conference Call


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SOURCE Par Pharmaceutical Companies, Inc.
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