KV Pharmaceutical Company has received two ANDA approvals from the U.S. Food and Drug Administration (FDA) to market Dextroamphetamine Sulfate 5mg. and 10 mg. Tablets.
These two new products, the sixth and seventh ANDA approvals received by the company this calendar year, will be marketed through the Company's generic marketing subsidiary, ETHEX Corporation.Dextroamphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures for a stabilizing effect in pediatric patients.Patients with the disorder may experience moderate to severe distractibility, short attention span, hyperactivity, emotional lability and impulsivity.It is also indicated for the treatment of Narcolepsy.
ETHEX's Dextroamphetamine Sulfate 5 mg. is AA-rated to Dextrostat Tablets (Shire) and Dexedrine Tablets (GlaxoSmithKline).The Company's Dextroamphetamine Sulfate 10mg. Tablet is AA-rated to Dextrostat Tablets (Shire).These two new ETHEX products will participate in a market that is approximately $20 million in the United States today.
Philip Vogt, President of ETHEX Corporation stated, "We are very excited about these two new approvals as they represent an expansion of our current product line in the Schedule II market. These two new approvals demonstrate our continuing success in the development and successful marketing of product from our internal development pipeline."