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Watson Receives FDA Approval for Generic Accuneb(R) |
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27 Sep 2007 |
Watson Pharmaceuticals, Inc. announced today that it has received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for albuterol sulfate inhalation solution in the 0.021% and 0.042% strengths
CORONA, CA, USA | September 26, 2007 | Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today 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 albuterol sulfate inhalation solution in the 0.021% (base) and 0.042% (base) strengths. Watson has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the 0.021% (base) strength. Watson's market exclusivity will begin upon commercial launch. Watson intends to launch its albuterol sulfate inhalation product immediately.
Albuterol sulfate is the generic equivalent to Dey, L.P.'s AccuNeb(R) Inhalation Solution, which is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease). For the 12-months ending June 2007, AccuNeb(R) had total U.S. sales of approximately $20 million, according to IMS Health data.
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.
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.
AccuNeb(R) is a registered trademark of Dey, L.P.
SOURCE: Watson Pharmaceuticals, Inc. |
