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KV Pharmaceutical Company, a fully integrated specialty pharmaceutical company that develops, manufactures, acquires and markets technology-differentiated branded products and generic/non-branded prescription pharmaceuticals, announced recently that it has received final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) to market its 50 mg strength of metoprolol succinate extended-release tablets. The Company expects to begin shipping immediately. This product is a generic version of AstraZeneca's branded product, Toprol-XL and the 50 mg strength recorded total branded and generic dollar volume in 2007 of $585M according to IMS America. The 50 mg strength is the largest of the four strengths in both units sold and dollar volume.

As a result of the 50 mg approval, KV is now offering the complete line of all four dosage strengths of metoprolol succinate extended-release tablets -- 200 mg, 100 mg, 50 mg and 25 mg. KV currently has a 77.8% and 77.4% market share for the 200 mg and 100 mg strengths, respectively. Based on the Company's first-to-file status on its ANDA for these two strengths, KV was accorded the benefit of a 180-day generic exclusivity period for the marketing of these two dosage strengths. Even though KV was not granted an exclusivity period for the 50 mg or 25 mg dosage strengths, the Company currently has a 23.5% market share for the 25 mg strength which was only approved by the FDA on March 20, 2008.

Marc S. Hermelin, Vice Chairman and Chief Executive Officer of KV Pharmaceutical stated, "Following today's approval, KV is now able to offer all four dosage strengths of metoprolol succinate extended-release tablets. We have achieved remarkable results marketing the 100 mg and 200 mg strengths of metoprolol succinate extended-release tablets and have demonstrated success marketing the 25 mg strength since we began shipping in March. With the 50 mg dosage strength now available, we expect the complete product line to continue to be a solid contributor to our growth in fiscal 2009 and beyond."

Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension used alone or in combination with other antihypertensive agents, for the long-term treatment of angina pectoris and for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.

About KV Pharmaceutical Company
KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures, markets and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products. The Company markets its technology-distinguished products through ETHEX Corporation, a national leader in pharmaceuticals that compete with branded products, and Ther-Rx Corporation, its branded prescription pharmaceutical subsidiary.

For further information about KV Pharmaceutical Company, please visit the Company's corporate website at www.kvpharmaceutical.com .

SOURCE: KV Pharmaceutical Company