FDA News

FDA Approves KV Pharmaceutical's Morphine ER 100 mg and 200 mg Tablets

(Oct 24, 2007)-- KV Pharmaceutical Company announced that it has received approval from the U.S.Food and Drug Administration (FDA) on its application for the 100 mg and 200 mg strengths of Morphine ER Tablets (MS Contin marketed by PurduePharma L.P.). This approval now allows ETHEX Corporation, KV's wholly-owned generic/non-branded subsidiary, to offer a full line of all strengths of this product.

While this is a highly genericized market, these two strengths have shown unit market growth year-over-year according to IMS. When comparing the 12 months ended August 2007 to the 12 months ended August 2006, the
total unit market for these two strengths grew approximately 12%. The entire market for all strengths represents an approximately $178 million annual opportunity.

ETHEX Corporation has commenced the launch of these two new strengths into its current line of 15 mg, 30 mg and 60 mg Morphine ER Tablets. The Company believes these two strengths will be a positive addition and will
allow ETHEX to increase its market share position for its full product line offering.

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