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Pernix Therapeutics Holdings, Inc. (“Pernix” or the “Company”) (NASDAQ: PTX), a specialty pharmaceutical company, today announced that its subsidiary, Hawthorn Pharmaceuticals, Inc., has received U.S. Food and Drug Administration (FDA) approval of a new drug application (NDA) for VITUZ® Oral Solution (hydrocodone bitartrate and chlorpheniramine maleate). VITUZ is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.
The Company today also announced that its subsidiary, Cypress Pharmaceuticals, Inc., was granted final approval by the FDA for an abbreviated new drug application (ANDA) for Mefenamic Acid Capsules USP, 250 mg. This product is the generic version of Ponstel Capsules, 250 mg, and is indicated for relief of mild-to-moderate pain in patients 14 years of age and older and the treatment of primary dysmenorrhea.
Cooper Collins, President and CEO of Pernix, said, “VITUZ broadens our cough and cold product line and is our first NDA approved by the FDA, since we closed the acquisition of Hawthorn and Cypress at the end of December 2012. We look forward to the launch of this new treatment option for cough and cold symptoms, which is expected prior to the fall of this year.”
Mr. Collins continued, “We are also pleased to receive regulatory approval from the FDA for Mefenamic Acid Capsules, a generic version of Ponstel capsules. We expect to launch this product in the second quarter of 2013.”
Indication for VITUZ®VITUZ® Oral Solution is a combination of hydrocodone bitartrate, an antitussive, and chlorpheniramine maleate, a histamine-1 (H1) receptor antagonist, indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold for adults 18 years of age and older.
Important Safety Information for VITUZ®VITUZ® is contraindicated in patients with known hypersensitivity to hydrocodone bitartrate, chlorpheniramine, or any of the inactive ingredients of VITUZ®; in patients receiving monoamine oxidase inhibitor (MAOI) therapy or within 14 days of stopping such therapy, and in patients with narrow angle glaucoma, urinary retention, severe hypertension or severe coronary artery disease. The possibility of tolerance and/or dependence, particularly in patients with a history of drug dependence, should be considered. Avoid in patients with head injury, intracranial lesions, or increased intracranial pressure. Exercise caution when using because of the potential for respiratory depression. Patients should be advised to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as VITUZ® Oral Solution may produce marked drowsiness. VITUZ® Oral Solution should not be taken with alcohol or other CNS depressants. Use with caution in patients with acute abdominal conditions and in patients with thyroid disease, Addison’s disease, prostatic hypertrophy, urethral stricture, or asthma.
The most common adverse reactions of VITUZ® Oral Solution include: Sedation, somnolence, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, nausea, psychic dependence, mood changes; blurred, double, or other visual disturbances; confusion, headache, euphoria, facial dyskinesia, feeling faint, lightheadedness, agitation, irritability, and tremor.