FDA News

FDA approves low-dose phentermine for obesity

The FDA has approved phentermine hydrochloride USP 8 mg, a low-dose medication for adults with obesity that can be taken up to three times daily, KVK Tech, Inc. announced in a press release.

The new lower-dose phentermine (Lomaira) is intended to be used for weight reduction as an adjunct to diet and exercise in adults with an initial BMI of at least 30 kg/m² or at least 27 kg/m² with at least one weight-related comorbidity, such as controlled hypertension, diabetes or high cholesterol.

"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,” Anthony Tabasso, president and chief executive officer of KVK Tech, said in a statement. “Appropriate patients can take Lomaira up to three times a day, before meals — not just in the morning as with the higher-dose formulations of phentermine. We developed Lomaira with this dosing flexibility and affordability in mind.”

Phentermine hydrochloride, an appetite suppressant, is the most commonly prescribed drug for weight loss. The drug is typically prescribed in doses ranging from 15 mg to 37.5 mg and taken before or within a few hours of breakfast. The usual adult dose of Lomaira is one tablet three times a day 30 minutes before meals. The butterfly-shaped tablet is scored to facilitate administering one-half of the usual dosage for patients not requiring the full dose, enabling health care providers and patients to work together to customize a weight-loss treatment plan to best meet each patient's needs.

Phentermine is not recommended for use in pediatric patients 16 years of age or younger. Late evening medication should be avoided because of the possibility of resulting insomnia.

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

The FDA has approved phentermine hydrochloride USP 8 mg, a low-dose medication for adults with obesity that can be taken up to three times daily, KVK Tech, Inc. announced in a press release.

The new lower-dose phentermine (Lomaira) is intended to be used for weight reduction as an adjunct to diet and exercise in adults with an initial BMI of at least 30 kg/m² or at least 27 kg/m² with at least one weight-related comorbidity, such as controlled hypertension, diabetes or high cholesterol.

"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,” Anthony Tabasso, president and chief executive officer of KVK Tech, said in a statement. “Appropriate patients can take Lomaira up to three times a day, before meals — not just in the morning as with the higher-dose formulations of phentermine. We developed Lomaira with this dosing flexibility and affordability in mind.”

Phentermine hydrochloride, an appetite suppressant, is the most commonly prescribed drug for weight loss. The drug is typically prescribed in doses ranging from 15 mg to 37.5 mg and taken before or within a few hours of breakfast. The usual adult dose of Lomaira is one tablet three times a day 30 minutes before meals. The butterfly-shaped tablet is scored to facilitate administering one-half of the usual dosage for patients not requiring the full dose, enabling health care providers and patients to work together to customize a weight-loss treatment plan to best meet each patient's needs.

Phentermine is not recommended for use in pediatric patients 16 years of age or younger. Late evening medication should be avoided because of the possibility of resulting insomnia.

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