K-V Pharma Soars On FDA Approval To Return Product To Market

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; [e-mail]