CHICAGO, Aug 4 (Reuters) - K-V Pharmaceutical, a
Bridgeton-Missouri based company focused on women's healthcare
products, filed for bankruptcy protection on Saturday, blaming
federal actions that kept it from getting "full value" of a drug
aimed at preventing premature births.
The company, founded in 1942, listed debts of $728.3 million
and assets of $236.6 million in a filing in bankruptcy court in
New York.
The company blamed the bankruptcy on its "inability to
realize the full value of Makena," the drug to help avoid
premature births, because of the Food and Drug Administration's
refusal to enforce orphan drug marketing exclusivity for it,
Thomas McHugh, the company's treasurer and vice president, said
in declaration filed with the court.
The company also said it was hurt by restrictions on
reimbursements imposed by state Medicaid agencies.
McHugh also blamed restrictions on manufacturing and
marketing of its other products that were imposed as a part of a
2009 consent decree with the Justice Department after a recall
of products, including some tablets that may have been
oversized.
In 2010, KV's Ethex unit pled guilty to failing to alert
drug authorities about pill manufacturing problems, and agreed
to pay a criminal fine of $23.4 million. The following year,
former CEO Mark Hermelin pled guilty to violating drug labeling
laws.
(Reporting by Ann Saphir)
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