Lannett Announces FDA Marketing Approval for Generic Phentermine
The US Food and Drug Administration (FDA) has granted marketing approval to Philadelphia-based Lannett Co. Inc. to market a generic version of Phentermine hydrochloride, a weight-reduction medication.
The FDA has approved its 30-milligram blue/white seed capsules for use as a short-term obesity treatment. It is a generic version of a product made by Novartis AG’s Sandoz unit.
Arthur Bedrosian, president and CEO of Lannett, said that the company intends to launch the new generic product during the current quarter. “Phentermine hydrochloride is an important new addition to the company’s growing offering of obesity management products, a large and underserved market,” Bedrosian said.
Phentermine hydrochloride is an amphetamine that helps suppress appetite and can help consumers lose weight when combined with a comprehensive program that includes diet, exercise, and behavior modification. It is prescribed for patients with a body mass index (BMI) of 30 kg/m2 or greater or for those with a lower BMI (27 or greater), but with the presence of obesity-related risk factors such as hypertension, diabetes, or hyperlipidemia.
Phentermine is usually taken as a single daily dose in the morning or three times a day 30 minutes before meals. Most people take the drug for 3-6 weeks, but the length of treatment depends upon the response. Phentermine may cause side effects such as dry mouth, unpleasant taste, and gastrointestinal symptoms such as diarrhea or constipation.