Suprenza
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`http://www.suprenza.com/[11/19/2015 1:59:49 PM]
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`Patient Support
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`Physician Support
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`Savings Card
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`Patient Savings Card
`Sample Request Form
`Prescribing Information
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`Welcome to the Suprenza Website
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`An interactive gateway to resources that will help set a course for weight-loss success.
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`*An important part of a successful weight-loss regimen.
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`Important Safety Information
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`Suprenza is a sympathomimetic amine anoretic indicated as a short-term adjunct (a few weeks) in a regimen of
`weight reduction based on exercise, behavioral modification and caloric restriction in the management of
`exogenous obesity for patients with an initial body mass index of greater than or equal to 30 kg/m2, or greater
`than or equal to 27 kg/m2 in the presence of other risk factors (eg, controlled hypertension, diabetes,
`hyperlipidemia). The limited usefulness of this class, including Suprenza should be measured against possible
`risk factors inherent in their use.
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`Suprenza is contraindicated in patients with a history of cardiovascular disease (eg, coronary artery disease,
`stroke, arrhythmias, congestive heart failure, uncontrolled hypertension), during or within 14 days following the
`administration of monoamine oxidase inhibitors, hyperthyroidism, glaucoma, agitated states, history of drug
`abuse, pregnancy, nursing, known hypersensitivity, or idiosyncracy to the sympathomimetic amines.
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`Coadministration of Suprenza with other drugs for weight loss is not recommended. Primary pulmonary
`hypertension (PPH) has been reported to occur in patients receiving a combination of phentermine with
`fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of Suprenza alone
`cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken phentermine
`alone. Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves,
`has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine
`or dexfenfluramine for weight loss. The possible role of phentermine in the etiology of these valvulopathies has
`not been established and their course in individuals after the drugs are stopped is not known. The possibility of
`the association between valvular heart disease and the use of Suprenza alone cannot be ruled out; there have
`been rare cases of valvular heart disease in patients who reportedly have taken phentermine alone.
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`Suprenza
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`The following adverse reactions to phentermine have been identified: Primary pulmonary hypertension and/or
`regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events,
`overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis, dryness of
`mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances, urticaria, impotence, changes
`in libido.
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`Click here for full Prescribing Information
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`Suprenza is a registered trademark of Citius Pharmaceuticals, LLC.
`Marketed by Prenzamax, LLC. Distributed by Akrimax Pharmaceuticals, LLC.
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`http://www.suprenza.com/[11/19/2015 1:59:49 PM]
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`Bass and Spangenberg
`Exhibit 1016