SILVER SPRING, Md. — The Food and Drug Administration has approved KVK Tech’s Lomaira (phentermine HCl), the company announced Tuesday. The drug is indicated for short-term use to aid in weight reduction in obese and overweight patients (patients with body mass indices of 30 or higher and 27 or higher, respectively) with at least one weight-related condition, including high blood pressure and diabetes.
The drug, which is meant to be used alongside a reduced-calorie diet and regular exercise, can be taken as many as three times a day before meals, the company said, noting that its aim was to provide an affordable medicine to aid in weight reduction. Patients who qualify for the Lomaira Lo-Cost Access program will pay no more than $0.50 per tablet during treatment.
“At KVK Tech, we are committed to developing high-quality, FDA-approved medicines that address unmet medical needs, while ensuring affordable options for all appropriate patients,” KVK Tech president and CEO “With Lomaira, we're giving physicians and patients access to a low-cost, low-dose version of a weight-reduction medicine, phentermine, that has been prescribed by physicians for over 50 years.”
The company expects Lomaira to be available by the end of September. The drug is available in 8-mg tablets.
"Obesity is a chronic metabolic disease that must be managed appropriately to reduce the risk of serious health conditions," Dr. Donna Ryan said. "Many physicians have used phentermine to help patients as part of a comprehensive weight-management plan. Now, the flexibility in dosing with Lomaira allows doctors to personalize dosing."