Drug Development
Pharmaceuticals company reports on filing, approval of ANDAs with the FDA
Published in Medical Letter on the CDC and FDA, October 17th, 2004
This is the company's first ANDA filing on behalf of FDC Ltd. and the second electronic submission. Under the terms of the December 2003 agreement, FDC will develop and manufacture the product, and Spectrum will be responsible for all regulatory, marketing and distribution matters in the United States.
The company also announced that it has received approval from the Office of Generic Drugs of the FDA for the ANDA...
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