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Lomaira FDA Approval History

FDA Approved: Yes (First approved September 13, 2016)
Brand name: Lomaira
Generic name: phentermine hydrochloride
Dosage form: Tablets
Company: KVK-Tech, Inc.
Treatment for: Weight Loss (Obesity/Overweight), Weight Loss (Obesity/Overweight)

Lomaira (phentermine hydrochloride) is a sympathomimetic amine anorectic used short-term for weight reduction in overweight or obese adults.

Phentermine hydrochloride, the active ingredient in Lomaira, is the most commonly prescribed drug for weight loss. In relatively short-term clinical trials, adult obese patients instructed in dietary management and treated with anorectic drugs lost more weight on average than those treated with placebo and diet.

Lomaira is indicated for use together with regular exercise and a reduced-calorie diet in patients with a Body Mass Index (BMI) of 27 or more, who have at least one weight-related condition such as controlled high blood pressure, diabetes, or high cholesterol. Lomaira tablets are butterfly shaped and scored, and are taken up to three times a day before meals.

Reported side effects of phentermine include pulmonary hypertension, valvular heart disease, palpitations, increased heart rate or blood pressure, insomnia, restlessness, dry mouth, diarrhea, constipation and changes in sex drive.

Development timeline for Lomaira

Sep 20, 2016Approval KVK Tech Announces FDA-Approval of Lomaira (phentermine hydrochloride USP) for Weight Reduction

Further information

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