CORONA, Calif., March 28 /PRNewswire/ -- Watson Pharmaceuticals, Inc.
(NYSE: WPI) announced today that the Food and Drug Administration (FDA) has
approved Watson's Abbreviated New Drug Application (ANDA) for Buspirone
Hydrochloride Tablets USP, 5 mg and 10 mg. As the first company to file a
Paragraph IV certification, Watson will be entitled to 180 days of exclusivity
on the 5 mg and 10 mg dosage forms. Buspirone hydrochloride is the generic
equivalent to Bristol-Myers Squibb's BuSpar(R) tablets, and is indicated for
the management of anxiety disorders or the short-term relief of the symptoms
of anxiety.
Watson intends to launch its buspirone 5 mg and 10 mg product immediately.
Watson does not anticipate that sales of this product will significantly
impact its financial results for the first quarter 2001 due to the limited
number of shipping days remaining in the first quarter.
Watson further reported that it had received tentative FDA approval for
its buspirone 15 mg product. Final FDA approval on Watson's buspirone 15 mg
product is anticipated after expiration of the exclusivity period awarded to a
third party on the 15 mg dosage form.
Statements in this press release that refer to Watson's estimated or
anticipated future results or other non-historical facts are forward-looking
statements. Such forward-looking statements reflect Watson's current
perspective of existing trends and information and represent Watson's judgment
only as of the date of this release. 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. These risks and uncertainties include, among
others, the inherent uncertainty associated with financial projections; market
acceptance of and continued demand for Watson's products; the impact of
competitive products and pricing; and, the outcome of litigation involving the
company and related costs and expenses and possible diversion of management's
time and attention arising from such litigation. The company disclaims any
intent or obligation to update these forward-looking statements. Additional
information concerning the factors that affect Watson's business can be found
in Watson's press releases as well as Watson's periodic public filings with
the Securities and Exchange Commission, including but not limited to Watson's
Annual Report on Form 10-K for the year ended December 31, 1999 and Form 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.
SOURCE Watson Pharmaceuticals, Inc.
-0- 03/28/2001
/CONTACT: Sara Swee, Director, Corporate Communications of Watson
Pharmaceuticals, Inc., 909-270-1400; or investors, Jim Byers, or media,
Christopher Katis, of Morgen-Walke Associates, Inc., 415-296-7383, for Watson
Pharmaceuticals, Inc./
/Company News On-Call: http://www.prnewswire.com/comp/112856.html or fax,
800-758-5804, ext. 112856/
