FDA approves Watson's generic AccuNeb

CORONA, Calif. The Food and Drug Administration has given final approval to Watson Pharmaceuticals for its application for the drug albuterol sulfate inhalation solution, the generic of AccuNeb, in the .021 and .042 percent strengths.

Watson has been awarded 180 days of market exclusivity for the .021 percent strength. Watson intends to launch its albuterol sulfate inhalation product immediately.

The drug is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma. AccuNeb, for the 12 months ended June 2007 had sales of about $20 million in the U.S., according to IMS Health data.

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