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Article: FDA finds dozens new deficiencies at Andrx.
- Article from:
- South Florida Sun-Sentinel (Fort Lauderdale, FL)
- Article date:
- April 25, 2006
CopyrightCOPYRIGHT 2006 South Florida Sun-Sentinal. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Byline: Glenn Singer
Apr. 25--Food and Drug Administration inspectors have uncovered more than two dozen new manufacturing deficiencies at Andrx Corp.'s generic drug plant in Davie, according to an agency report released Monday.
Officials in Maryland must now decide whether to continue punishing Andrx with an existing ban on new drug approvals or impose tougher penalties. However, if FDA officials believe Andrx has made progress toward correcting deficiencies, they could lift the ban on new approvals imposed last summer. The situation is particularly crucial because Andrx agreed in March to a $1.9 billion buyout -- $25 a share -- by Watson ...