FDA investigation prompts suspension

According to the FDA and a press release from KV Pharmaceuticals, on January 22, 2009, the manufacturer voluntarily suspended the manufacturing and shipping of all of its products, other than certain products that it distributes but does not manufacture and has recalled most of the products on its shelves. The action comes after the FDA inspected the company’s operations and inventory in December of 2008 amid controversy over its distribution of oversized drugs. The Securities and Exchange Commission (SEC) has also inquired into statements made by the company to allegedly inflate the price of its stock.

The company has terminated many of the its executive officers, appointed a special committee to review its practices and is working with third-party consulting group, Lachman Consultant Services, Inc. and the FDA to review manufacturing and packaging processes.

Recalled products

The company markets its technology distinguished products through ETHEX Corporation, a generic pharmaceuticals company and Ther-Rx Corporation, its branded drug subsidiary. For a list of recalled products, see the FDA’s press release by clicking here.

According to the press release, “Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.”

Only a year ago, the company bought rights to Gestiva, a drug meant to prevent preterm birth in women with a history of the problem. It hoped to have FDA approval of the drug by late 2008, but the FDA is now requiring the company to do additional studies before the drug can be sold in the marketplace. Due to the challenges the company now faces, it says that it is unlikely to realize any revenue on the product in the short term.