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FDA Lays Out Some Fiscal 2013 Generic User Fee Rates; ANDAs to Cost About $50K
Teva Pharmaceuticals has resolved a long-outstanding warning letter for its Irvine, Calif., plant, the company said on its third-quarters earnings call Nov. 1. Upgrades to the building and systems, as well as to manufacturing and quality processes, led to last month’s resolution of the letter, CEO and President Jeremy Levin said. The facility’s focus continues to be on producing the life-saving drugs on the FDA’s drug shortage list.
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