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Executive Summary

ROXANE INTENSOL CONCENTRATED ORAL SOLUTION LINE EXPANSION to include meperidine and diphenhydrmaine through the ANDA procedures is being sought by the firm. In recent petitions to FDA, Roxane asked the agency for a determination of ANDA suitability for Intensol products containing the two drugs. According to the petitions, the firm currently markets concentrated oral solution dosage forms of dexamethasone, chlorpromazine HCl, morphine sulfate and dihydrotachysterol under its Intensol line, and has Intensol ANDAs pending for another two products, prednisone and hydrochlorothiazide. Designed for adults who cannot swallow tablets or capsules, the Intensol line "is developed to contain the standard therapeutic adult dose in a 0.5 ml or 1.0 ml volume," Roxane said. In addition, the firm asserted that the products provide "better accuracy or dosage as compared to the traditional teaspoonful(s)," and "ease of titration while seeking the effective dose level." Products in the Intensol line "are formulated without sugar, dye, saccharin and alcohol (if possible)," the firm stated. Noting that "the growing population of the elderly and the care of them by others is also a consideration," Roxane said: "The need to crush tablets or empty capsules will be obviated by Intensols." "Because the preparation is bland and the dose a small amount of liquid, the formulation can be administered directly or in as little as 30 ml of liquid or semi-solid food." The solution may also be administered through a nasogastric tube. Another advantage cited by the firm is more convenient storage of the product's standardized 30 ml bottles as compared to "pint or larger container as standard for most liquids." Roxane currently markets meperidine HCl in 500 ml bottles containing a concentration of 50 mg/ml, and diphenhydramine HCl in unit dosage cups containing 25 mg of diphenhydramine HCl in 10 ml solution. The firm noted that "there are many more products under development as part of Roxane's Intensol product line."

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