News

KV Pharmaceutical Company announces approval of generic version of Toprol-XL®

St. Louis, Missouri
May 15, 2008

KV Pharmaceutical Company announced that it has received US FDA approval for the marketing and manufacture of its Abbreviated New Drug Application (ANDA) of 50 mg strength of metoprolol succinate extended-release tablets. This product is a generic version of AstraZeneca's branded product, Toprol-XL®. 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. The 50 mg strength is the largest of the four strengths in units sold.

Speaking on this, Marc S. Hermelin, Vice Chairman and Chief Executive Officer, KV Pharmaceutical, said, "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."