KV is Now Offering The Complete Line of All Four Dosage Strengths of Generic Metoprolol Succinate Extended-Release Tablets Following Approval of
the 50 mg Tablet
ST. LOUIS, May 15 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company (NYSE: KVa/KVb), a fully integrated specialty pharmaceutical company that develops, manufactures, acquires and markets technology-differentiated branded products and generic/non-branded prescription pharmaceuticals, announced today 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(R) and the 50 mg strength recorded total branded and generic dollar volume in 2007 of $585 million 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
|SOURCE KV Pharmaceutical Company|
Copyright©2008 PR Newswire.
All rights reserved