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PARSIPPANY, N.J. — Watson Pharmaceuticals Inc. has received approval from the Food and Drug Administration for budesonide inhalation suspension 0.25mg/2ml and 0.5mg/2ml (unit-dose ampules), an asthma medication for children.
Watson said Wednesday that its product is the generic equivalent of AstraZeneca’s Pulmicort Respules.
The company noted that it’s currently involved in patent litigation with AstraZeneca concerning the product. Plans call for Watson to launch its product this year, subject to obtaining a favorable outcome on an anticipated motion for a preliminary injunction in the litigation.
Pulmicort Respules is a maintenance medicine for controlling and preventing asthma symptoms in children ages 12 months to 8 years.For the 12 months ended May 31, the medication had total U.S. sales of about $1.1 billion, according to IMS Health data cited by Watson.
