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AIDS Therapy

NDA submitted as treatment for weight loss in AIDS patients

Published in Drug Week, July 30th, 2004

Par Pharmaceutical Companies, Inc., (NYSE:PRX) announced that it has submitted a New Drug Application (NDA), pursuant to Section 505(b)(2) of the U.S. Federal Food Drug and Cosmetic Act, to the U.S. Food and Drug Administration (FDA) seeking marketing clearance for megestrol acetate oral suspension NanoCrystal Dispersion (NCD).

The new NCD formulation is a line extension of Par's currently marketed megestrol acetate oral suspension.

Megestrol acetate oral suspension NCD represents an advanced formulation of megestrol acetate oral suspension that utilizes NanoCrystal Dispersion technology to improve the bioavailablity of the drug, compared to...

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