FDA approves Lannett's Diethylproprion HCl Tablets ANDA for anti-obesity treatment

Lannett Company, Inc. (NYSE AMEX: LCI) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) of Diethylproprion HCl Tablets, 25 mg. Diethylproprion HCl Tablets, 25 mg, is therapeutically equivalent to the reference listed drug, Tenuate^® Tablets, 25 mg, of Watson Pharmaceuticals. Retail pharmacy sales of Diethylproprion HCl Tablets, 25 mg, at Average Wholesale Price (AWP) were approximately $3.3 million for the year ending May, 2011, according to Wolters Kluwer. Additional sales of this drug are made through bariatric clinics. The company expects to commence shipping the product shortly.

"Recognizing the struggle that many have with losing weight, we are pleased to offer Diethylproprion HCl Tablets, 25 mg, which further rounds out our portfolio of anti-obesity treatments," said Arthur P. Bedrosian, president and chief executive officer of Lannett. "We have 16 ANDAs currently pending at the FDA and are optimistic that a number of them will be approved in the coming months."

Diethylproprion HCl is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction.