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
injection (IV) (at a rate not to exceed 12.5mg/min) without the need for a
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-
study, reporting safety result on 1,097 patients.
Ferrlecit® labeling required a prior test dose to
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
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
``These new labeling changes, combined with the previously
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
``We believe that with FDA's approval of this improved labeling,
Watson can further differentiate Ferrlecit® from other competitive
Ferrlecit® is indicated for use as a first line treatment
deficiency anemia in patients undergoing chronic hemodialysis who are
receiving supplemental erythropoeitin therapy.
Inc., headquartered in Corona, California, is
engaged in the development, manufacture and sale of proprietary and off-
Watson pursues a strategy of generating revenue
through established proprietary and off-patent businesses, capitalizing on
proven ability to support the development and commercialization of a broad
range of proprietary and off-patent pharmaceutical products.
contained in this press release that refer to
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.
disclaims any intent or obligation to update these forward-looking
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;
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,
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
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.
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