FDA Approves Lomaira as Adjunct Tx in Weight Loss
The Food and Drug Administration (FDA) has approved Lomaira (phentermine HCl; KVK Tech) tablets as a short-term (a few weeks) adjunct in a regimen for weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity in patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (eg, controlled hypertension, diabetes, hyperlipidemia).
Lomaira, a sympathomimetic amine anoretic, has similar pharmacologic activity to prototype drugs in this class used for obesity. It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.
In short-term clinical trials, obese adult patients instructed in dietary management and treated with anoretics lost more weight on the average than those treated with placebo and diet. Phentermine HCl is not recommended for use in pediatric patients aged ≤16 years.
Lomaira is a CIV controlled substance. It will be available as 8mg scored tablets in 30-, 60-, 90-, 250-, 500-, and 1000-count bottles. It is anticipated to launch on September 26, 2016.
For more information call (215) 579-1842 or visit Lomaira.com.