The US Food and Drug Administration (FDA) has approved an abbreviated new drug application for phentermine hydrochloride blue/white seed capsules USP 30mg for obesity management.
The drug, developed by Lannett Company, is a generic equivalent of Sandoz’s reference-listed drug phentermine hydrochloride capsules USP 30mg.
Phentermine hydrochloride is used as a short-term adjunct in a weight reduction regimen for patients who have exogenous obesity and also face other risk factors such as hypertension and diabetes.
The US sales of phentermine hydrochloride capsules in 2009 were approximately $36.5m at average wholesale price, according to Wolters Kluwer.
Lannett Company said it is planning to launch phentermine hydrochloride in the first quarter of fiscal 2011.