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FDA Approves Zutripro

FDA Approves Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine HCl) Oral Solution

MADISON, Miss.--(BUSINESS WIRE)--Jun 13, 2011 - Cypress Pharmaceutical announced today that the Food and Drug Administration (FDA) approved a new drug application (NDA) for Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine HCl) Oral Solution (CIII). The FDA also approved Rezira (hydrocodone bitartrate and pseudoephedrine HCl) Oral Solution (CIII). Both products are indicated for the relief of cough and symptoms associated with the common cold.

Zutripro and Rezira Oral Solutions are the only FDA approved hydrocodone cough and cold combinations containing a nasal decongestant1. The approval of Zutripro and Rezira Oral Solutions marks the first NDA approval by the FDA for a liquid hydrocodone cough medication since 19901.

These products will be marketed by Hawthorn Pharmaceuticals, a subsidiary of Cypress Pharmaceutical, Inc.

"Currently, there are very few prescription products for patients suffering from cough and the symptoms associated with the common cold," said Chris Smith, EVP of Sales for Hawthorn Pharmaceuticals. "With Zutripro and Rezira Oral Solutions, healthcare practitioners finally have more options when treating patients suffering from a cough and symptoms associated with the common cold. Additionally, Zutripro and Rezira both contain a decongestant which is very beneficial considering the fact that one of the most common symptoms of the common cold is nasal congestion.2"

Zutripro and Rezira Oral Solutions are available through all national drug wholesalers, as well as chain drug stores and other distribution channels and will begin shipping immediately. Zutripro and Rezira Oral Solutions are available by prescription only in the United States.

About Zutripro

Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride) Oral Solution (CIII) is indicated for the relief of cough and nasal congestion associated with common cold and relief of upper respiratory allergy symptoms including nasal congestion in adults 18 years of age and older.

Important Safety Information

Zutripro Oral Solution is contraindicated in individuals with hypersensitivity to hydrocodone, pseudoephedrine HCl, chlorpheniramine, or any of the inactive ingredients; individuals receiving monoamine oxidase inhibitor (MAOI) therapy or within 14 days of stopping such therapy; and individuals 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, intra-cranial lesions, or increased intracranial pressure. 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 Zutripro Oral Solution may produce marked drowsiness. Zutripro 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 diabetes, thyroid disease, Addison's disease, prostatic hypertrophy, urethral stricture, or asthma.

The most common adverse reactions of Zutripro Oral Solution are CNS and cardiovascular reactions including the following: Sedation, somnolence, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes, nervousness, or sleeplessness; blurred, double, or other visual disturbances; confusion, headache, euphoria, facial dyskinesia, feeling faint, lightheadedness, agitation, restlessness, insomnia, irritability, or tremor.

About Cypress Pharmaceutical, Inc.

Cypress Pharmaceutical, Inc., founded in 1993, is a specialty pharmaceutical company that develops, markets and distributes generic prescription pharmaceutical products to leading national pharmaceutical wholesalers, chain drug stores, distributors, and other retail merchandisers.

About Hawthorn Pharmaceuticals, Inc.

Hawthorn Pharmaceuticals, Inc, founded in 1998, is a commercial stage specialty pharmaceutical company that develops and markets prescription pharmaceutical products to multiple physician specialties. Hawthorn's broad pipeline represents the therapeutic areas of respiratory, nephrology, dermatology, oncology, CNS and neurology. The company has established strategic corporate alliances with multinational companies. For more information, please visit the Hawthorn Pharmaceuticals web site at www.hawthornrx.com.

References:
1. Drugs@FDA search. 9 June 2011.
2. Allen G, Kelsberg G, Jankowski T. Do nasal decongestants relieve symptoms? Journal of Family Practice 2003; 52; No. 9.

Contact: Cypress Pharmaceutical, Inc.

Posted: June 2011

Zutripro (chlorpheniramine, hydrocodone and pseudoephedrine) FDA Approval History

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