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Also, FDA stated that supply issues, convenience, and lower cost do not count as clinical need under this pathway

On its own, phentermine produces modest weight loss of 3-5% of body weight

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Niacinamide at the doses used in this formulation does not typically cause the flushing associated with nicotinic acid

However, the high price of the drug without insurance coverage has been in the spotlight, particularly since some insurance companies do not approve the drug