 |
Article Review/Hyperlink
|
Watson Pharmaceutical Press Release
Test dose no longer required in labeling for Ferrlecit® - sodium iron gluconate
Press Release (Feb) 01:Press rel., 2001
CORONA, Calif., Feb. 8 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI - news) today announced that the Food and Drug Administration (FDA) has approved Watson's Supplemental New Drug Application (SNDA) for its injectable iron therapy product, Ferrlecit® (sodium ferric gluconate complex in sucrose injection). New labeling for Ferrlecit® was approved as part of the SNDA, allowing undiluted intravenous injection (IV) (at a rate not to exceed 12.5mg/min) without the need for a test dose. Additionally, the bold type in the label's warnings section has been eliminated in the new Ferrlecit® label. The SNDA was based upon interim data from a single dose, placebo-controlled, crossover, post- marketing study, reporting safety result on 1,097 patients.
Previously, Ferrlecit® labeling required a prior test dose to confirm lack of hypersensitivity and allergic reactions and required that both the test dose and subsequent therapeutic doses be diluted in normal saline and administered as IV infusions over extended periods. The new labeling should allow clinicians greater convenience in administration by eliminating the need for a test dose and allowing undiluted injections of the therapeutic dose (125mg) over a period of 10 minutes. Physicians should carefully review the Ferrlecit® labeling to understand the risks associated with the use of the product.
``These new labeling changes, combined with the previously announced Ferrlecit® specific code for Medicare reimbursement, should provide clinicians with even greater flexibility in their utilization of Ferrlecit®,'' said Allen Chao, Ph.D., Watson's Chairman and Chief Executive Officer. ``We believe that with FDA's approval of this improved labeling, Watson can further differentiate Ferrlecit® from other competitive products.''
Ferrlecit® is indicated for use as a first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy.
Watson Pharmaceuticals, Inc., headquartered in Corona, California, is engaged in the development, manufacture and sale of proprietary and off- patent pharmaceutical products. Watson pursues a strategy of generating revenue through established proprietary and off-patent businesses, capitalizing on its proven ability to support the development and commercialization of a broad range of proprietary and off-patent pharmaceutical products.
Statements contained in this press release that refer to Watson's estimated or anticipated future results, product development efforts or performance or other non-historical facts are forward-looking statements and reflect Watson's current analysis of existing trends and information. Watson disclaims any intent or obligation to update these forward-looking statements. These forward-looking statements involve risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such statements. Such risks and uncertainties include, among others, timely and successful implementation of strategic initiatives; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; market acceptance of and continued demand for Watson's products; the impact of competitive products and pricing; the availability and pricing of third party sourced products and materials; successful compliance with governmental regulations; uncertainties related to the timing and outcome of litigation; and such other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Form 10-K for the year ended December 31, 1999, Forms 10-Q for the quarters ended March 31, June 30 and September 30, 2000 and Form 8-K filed on January 30, 2001.
This and past press releases of Watson Pharmaceuticals, Inc. are available at Watson's website at www.watsonpharm.com. In addition, press releases are available through PR Newswire's Company On-Call fax service at 800-758-5804, extension 112856, and at www.prnewswire.com.
| Related Folders: |
|
|
