Generic Drugs
FDA accepts NDA filing for megestrol acetate oral suspension NCD
Published in Medical Letter on the CDC and FDA, October 17th, 2004
The assigned filing date for the NDA is August 28, 2004 with a corresponding user fee goal date of April 29, 2005. On June 29, 2004, Par submitted the NDA pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
The new NCD formulation is a line extension of Par's currently marketed megestrol acetate oral suspension. This formulation utilizes NanoCrystal Dispersion technology to improve the...
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