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FDA Issues Approvable Letter for Intal HFA

BRISTOL, Tenn.— November 3, 2003 —King Pharmaceuticals, Inc. (NYSE:KG) announced today the receipt of an approvable letter for Intal® HFA (cromolyn sodium) from the U.S. Food and Drug Administration (“FDA”). Intal® HFA, a new inhaler formulation of King’s currently marketed product Intal® (cromolyn sodium) for the long-term management of asthma, utilizes the environmentally friendly propellant hydrofluoroalkane (“HFA”).

Jefferson J. Gregory, Chairman and Chief Executive Officer of King, stated, “Intal® HFA is an important product line extension. With a patent in the United States until September 2017, Intal® HFA provides us with a long-term exclusive respiratory product with positive differentiating attributes which include its unique mechanism of action and excellent safety profile, the latter of which is extremely important for pediatric patients and in other patient sub-populations for whom safety is a particular concern.”

Mr. Gregory noted, “The approvable letter provides that final approval for the New Drug Application (“NDA”) covering Intal® HFA is subject to addressing certain FDA comments solely pertaining to the chemical, manufacturing and controls section of the New Drug Application (“NDA”) covering the product. We anticipate that these comments can be adequately addressed in a timeframe that would potentially allow for final FDA approval of the NDA for Intal® HFA during the second half of 2004.”

Source: King Pharmaceuticals

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