CORONA, Calif., Sept. 26 /PRNewswire-FirstCall/ -- 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.
For press releases and other company information, visit Watson Pharmaceuticals' Web site at http://www.watsonpharm.com.
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|SOURCE Watson Pharmaceuticals, Inc.|
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