FDA approves Lannett's supplemental ANDA for Phentermine HCl to treat obesity

Lannett Company, Inc. (NYSE AMEX: LCI) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its supplemental Abbreviated New Drug Application (ANDA) for Phentermine HCl Capsules, 15 mg. Sales of Phentermine HCl Capsules, 15 mg, at Average Wholesale Price (AWP) were approximately $11 million for the year ending December 2011, according to Wolters Kluwer. Additional sales of this drug are made through bariatric centers. The company expects to commence shipping the product shortly.

"We have a deep pipeline that includes several late-stage, large market opportunity drugs, and an active product development program focused on expanding our pain management franchise," said Arthur P. Bedrosian, president and chief executive officer of Lannett. "Over the past seven months we have received nine product approvals, which included one New Drug Application, one supplemental ANDA and seven ANDAs. We especially would like to thank our local FDA representatives, as well as the reviewers at the Office of Generic Drugs, who were helpful in getting these products approved."

Phentermine Hydrochloride (HCl) is indicated for the short-term management of obesity.