FDA Adds To Unapproved Drug Initiative Scorecard With Action Against KV
Two weeks after FDA officials attempted to explain how well the Center for Drug Evaluation and Research's unapproved drug initiative is working, the agency showed how action often speaks louder than words
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KV Pharmaceutical Pledges To Improve Finances, But NYSE Demands Action
Already plagued by scandal, KV Pharma is subject to NYSE delisting if overdue 2009 annual report is not filed soon.
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Certain products will not be distributed until approved via NDA or ANDA processes.
Gestiva Approval Unlikely In FY 09; KV Pharmaceutical Admits Credit Fumbles
Firm halts manufacturing and distribution of nearly all products.