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news.The FDA has approved Sepracor's new drug application for Xopenex HFA, a metered-dose inhaler for the treatment or prevention of bronchospasm in those aged four years and older.
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Sepracor’s Xopenex (levalbuterol tartrate) metered-dose inhaler (MDI) utilizes state-of-the-art HFA technology and does not contain a CFC propellant. Sepracor and 3M’s drug delivery systems division are collaborating under an agreement that includes scale-up, manufacturing and supply of the Xopenex HFA. The collaboration combines Sepracor’s short-acting beta-agonist, Xopenex, and 3M’s expertise in manufacturing MDIs.
“We are extremely pleased that the Xopenex HFA MDI received first-cycle approval from the FDA,” said W James O’Shea, president and COO at Sepracor. “It remains our target to launch Xopenex HFA around the end of the year, during the peak asthma season.”
Sepracor currently markets Xopenex inhalation solution, a short-acting bronchodilator indicated for the treatment or prevention of bronchospasm in patients six years of age and older with reversible obstructive airway disease. Revenues for this product for the 12 months ended December 31, 2004 were approximately $319.8 million.