K-V Pharmaceutical Co. (KVA, KVB) has received permission from
the U.S. Food and Drug Administration to return its first product
to market following a successful inspection of facilities last
month of the specialty-drug company.
Its Class A shares surged 59% premarket to $2.69. The stock had
been down 54% this year.
The company has permission to manufacture and market two
versions of its Micro-K, a potassium supplement. It is the latest
in a number of regulatory and compliance issues the company has
dealt with in recent years.
K-V stopped manufacturing and shipping all of its products in
early 2009 and recalled most products already on the market,
including Toprol, as it dealt with an FDA investigation into
compliance matters and management misconduct, among others.
The company hadn't expected to be able to ship any product
before the fourth quarter.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481;
Tess.Stynes@dowjones.com