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ROXANE SEEKING ANDA ROUTE FOR DIAZEPAM AND INDOMETHACIN ORAL SOLUTIONS

Executive Summary

ROXANE SEEKING ANDA ROUTE FOR DIAZEPAM AND INDOMETHACIN ORAL SOLUTIONS among five ANDA suitability requests pending for the firm at FDA. The petitions are for major therapeutic products using the company's Intensol concentrated oral solution. Roxane is also petitioning for ANDA suitability of haloperidol, flurazepam and furosemide in Intensol formulations. Roxane already markets several products in its Intensol line. Among these are dihydrotachysterol, dexamethasone, hydrochlorothiazide, morphine sulfate and chlorpromazine hydrochloride. An ANDA is pending for prednisone and the company said in its haloperidol Intensol petition that "many more products [are] under development as a part of Roxane's Intensol product line." The Intensol line was designed "to offer a valuable dosage form alternative for greater compliance; for adults who cannot swallow tablets or capsules; for better accuracy of dosage as compared to the traditional teaspoonful(s); for ease of titration while seeking the effective dose level; and for administration through a nasogastric tube." In addition, Roxane predicted that concern over care for the growing population of elderly may increase demand for its Intensol products. "The need to crush tablets or empty capsules will be obviated by the Intensols," the petitions state. Roxane also notes that "storage of the bottle in a medication cart or on shelves or in drawers is more convenient because of the small size, compared to a pint or larger container as standard for most liquids."

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