Lannett Company, Inc. has received approval from the US FDA for the Abbreviated New Drug Application (ANDA) of Phentermine Hydrochloride Tablets 37.5mg. The company expects to commence marketing this product in June 2005.
Phentermine Hydrochloride is indicated for the short-term management of obesity and is the generic equivalent of Adipex-P, marketed by Gate Pharmaceuticals, a division of Teva Pharmaceutical Industries.
"Phentermine is the second product approval Lannett has received this year. We currently have nine applications pending at the FDA and a number of other products in various stages of development that will further expand our product offering," said Arthur Bedrosian, president of Lannett.
According to NDC Health, the total US market for Phentermine Hydrochloride 37.5 mg tablets is approximately $84 million. Currently, there are five other generic suppliers marketing this product.