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> Email this story to a friend Watson Pharmaceuticals (WPI) Receives FDA Approval For Buspirone Hydrochloride Tablets USP, 5 Mg And 10 Mg 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/ Related Companies Food and Drug Administration (FDA): Profile, News Mylan Laboratories Inc.: Profile, News, Full Quote All stock quotes current as of March 30, 2001 (15 min. delayed) Watson Pharmaceuticals, Inc.: Profile, News, Full Quote All stock quotes current as of March 30, 2001 (15 min. delayed) Related News News Categories: Approvals, Product News Disease Categories: Anxiety Clinical Development: Anxiety BioSpace News Reader > Next story: aaiPharma Inc. (AAII) Announces Flutamide Patent Issuance And Receipt Of First Tentative ANDA Approval For Flutamide By The FDA < Previous story: $4 Billion Shire Pharmaceuticals Group PLC (SHPGY) - BioChem Pharma Inc. (BCHE) Merger Rejected ### Email this news story to a friend:
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