FDA Approves KV Pharmaceutical's Morphine ER Tablets
Morphine ER Tablets
KV Pharmaceutical Company has received approval from FDA on its application for the 100 mg and 200 mg strengths of Morphine ER Tablets (MS Contin marketed by Purdue Pharma 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.