Lannett receives ANDA approval for Phentermine HCl capsules
Lannett Company has received FDA approval for its supplemental abbreviated new drug application (ANDA) for Phentermine HCl capsules, 15mg.
Phentermine Hydrochloride (HCl) is indicated for the short-term management of obesity.
According to Wolters Kluwer, sales of Phentermine HCl capsules, 15mg, at Average Wholesale Price (AWP) were approximately $11m for the year ending December 2011.
Lannett president and CEO Arthur Bedrosian said their pipeline includes several late-stage, large market opportunity drugs, and an active product development program focused on expanding their pain management franchise.
"Over the past seven months we have received nine product approvals, which included one New Drug Application, one supplemental ANDA and seven ANDAs," Bedrosian added.
"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."
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