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NORTHVALE, N.J. — Elite Pharmaceuticals Inc. has received approval from the Food and Drug Administration for generic phentermine capsules.
The company said Monday that the product comes in dosages of 15 mg and 30 mg.
An appetite suppressant, phentermine is used with diet and exercise to treat obesity in people with risk factors such as hypertension, high cholesterol or diabetes.
Elite, however, also announced Monday that the launch of its product likely will be delayed because the sole supplier of the active pharmaceutical ingredient approved for the phentermine capsule has restricted the amount of API available.
The company added that the supply restriction also prevents Elite and its sales and marketing partner from meeting rising demand for the phentermine 37.5 mg tablets and stands to restrict sales of that product.
"Elite believes the supplier is wrongfully limiting supply," the company said in a statement. "If Elite is unable to timely resolve this dispute in a reasonable manner then, unless and until Elite is able to obtain adequate amounts of API, it will not be able to sustain or grow the sales of the generic phentermine products. Elite has begun to qualify an alternative supplier, but qualification of an alternative supplier, due to FDA requirements, will entail a significant amount of time and could be expected to take 12 months or longer."
