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KV Pharmaceutical Receives FDA Approval For Generic Equivalent to Cardiovascular Drug IMDUR®

ST. LOUIS, March 20, 2000- KV Pharmaceutical Company announced today that it has received notice from the Food and Drug Administration of the approval of KV Pharmaceutical's, Abbreviated New Drug Application ("ANDA") for Isosorbide-5-Mononitrate Extended Release Tablets in 30mg, 60 mg and 120 mg. This product, a generic equivalent to the cardiovascular drug IMDUR®, utilizes the proprietary KV/24® once-daily extended release technology. 

KV Pharmaceutical Company is the first company to receive FDA approval to market all three strengths of Isosorbide Mononitrate ER Tablets -- the 30 mg., 60 mg. and 120 mg. The product will be marketed by ETHEX Corporation, KV's wholly owned subsidiary that markets technology distinguished generic products. Cardiovascular drugs are a core therapeutic category for ETHEX. The product is expected to be shipped shortly.

ETHEX Isosorbide Mononitrate ER Tablets is an AB-rated generic alternative to IMDUR® Tablets by Key Pharmaceuticals (part of Schering Corporation). According to IMS America, 1999 annual sales for IMDUR® Tablet were approximately $180 million. Isosorbide-5-Mononitrate is often prescribed for people who may suffer from angina pectoris due to coronary artery disease.

Marc S. Hermelin, Vice Chairman and CEO of KV Pharmaceutical, stated: "This approval marks the first of a number of ANDAs that the Company has pending at the Food and Drug Administration, in addition to a pipeline of products currently at various stages of development in our internal research and development pipeline. This ANDA approval indicates that we are expected to be more active in leveraging our R&D strength to create important new products for our generic drug division, ETHEX."


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