Watson Receives FDA Approval For Generic DuoNeb(R)

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Respiratory / Asthma;  Pharma Industry / Biotech Industry
Article Date: 03 Jan 2008 - 0:00 PDT

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Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Ipratropium Bromide and Albuterol Sulfate Inhalation Solution in the 0.5 mg/3 mg strength.

Watson's Ipratropium Bromide and Albuterol Sulfate product is the generic equivalent to Dey, L.P.'s DuoNeb(R), which is indicated for the treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) in patients requiring more than one bronchodilator. For the 12 months ending September 2007, DuoNeb(R) and its generic equivalents had total U.S. sales of approximately $265 million, according to IMS Health data. Watson intends to launch its Ipratropium Bromide and Albuterol Sulfate product immediately.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.

For press releases and other company information, visit Watson Pharmaceuticals' Web site at http://www.watsonpharm.com.

Forward-Looking Statement

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in 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, 2006.

DuoNeb(R) is a registered trademark of Dey, L.P

Watson Pharmaceuticals, Inc.
http://www.watsonpharm.com