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.

Patients who wish to take phentermine should be aware of the following advice from the National Institutes of Health:

• Tell your doctor and pharmacist if you are allergic to phentermine or any other drugs.
• Tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially fluoxetine (Prozac), fluvoxamine (Luvox), guanethidine, insulin, MAO inhibitors [phenelzine (Nardil) and tranylcypromine (Parnate)] even if you stopped taking them within the past 2 weeks, medications for weight loss and depression, paroxetine (Paxil), sertraline (Zoloft),and vitamins.
• Tell your doctor if you have or have ever had heart disease, high blood pressure, arteriosclerosis (narrowing of the arteries), hyperthyroidism (overactive thyroid gland), diabetes, glaucoma, or a history of drug abuse.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking phentermine, call your doctor.
• You should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• Remember that alcohol can add to the drowsiness caused by this drug.
• If you have diabetes, you may need a larger dose of insulin while taking phentermine. Call your doctor if you have questions or problems.
• When taking phentermine, if you experience any of the following symptoms, call your doctor immediately: increased blood pressure, heart palpitations, restlessness, dizziness, tremor, insomnia, shortness of breath, chest pain, or swelling of the legs and ankles.

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