Perennial Allergic Rhinitis And Chronic Urticaria In Children - FDA Approves Cetirizine Hydrochloride Oral Solution

Main Category: Allergy
Also Included In: Pediatrics / Children's Health;  Dermatology;  Regulatory Affairs / Drug Approvals
Article Date: 16 Oct 2008 - 7:00 PST

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Cypress Pharmaceutical, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted final approval of the company's abbreviated new drug application (ANDA) for the prescription and over-the-counter versions of Cetirizine Hydrochloride Oral Solution, 1 mg/1 mL.

Cypress' Cetirizine HCl Oral Solution is the AA-rated generic equivalent to McNeil Consumer Healthcare's Zyrtec® Oral Solution. The prescription version of Cetirizine HCl Oral Solution is used for the relief of symptoms associated with perennial allergic rhinitis in children 6 to 23 months of age, and for chronic urticaria (hives) in children 6 months to 5 years of age. The over-the-counter version of Cetirizine HCl Oral Solution is an antihistamine used for the relief of sneezing, runny nose, itchy, watery eyes and itchy throat or nose due to indoor and outdoor allergies for individuals 2 years and older and for the relief of itching due to hives for individuals 6 years and older.

Cypress' Cetirizine HCl Oral Solution will be available through all the national drug wholesalers and chain drug stores and will begin shipping immediately.

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. In 1999, Cypress established a specialty branded business, Hawthorn Pharmaceuticals, to market a line of internally developed pharmaceutical products directly to physician specialties through its nationwide sales force.

Cypress has an aggressive product development pipeline including new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with over 35 products in various stages of development. Cypress currently has 13 submissions with the Food and Drug Administration (FDA) with up to 8 submissions expected to be filed in 2008.

Cypress and Hawthorn have successfully signed several in-licensing agreements with multinational companies in the past several years and will continue to utilize strategic alliances as part if it's overall pharmaceutical pipeline.

http://www.cypressrx.com
http://www.hawthornrx.com