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Cypress wins FDA approval for generic allergy drug

Cypress Pharmaceutical, a specialty pharmaceutical company, has announced that the FDA has granted final approval of the company's abbreviated new drug application for the prescription and over-the-counter versions of Cetirizine hydrochloride oral solution, 1mg/1ml.

Cypress’s 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 six to 23 months of age and for chronic urticaria in children six months to five 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 two years and older and for the relief of itching due to hives for individuals six years and older.

Cetirizine HCl oral solution will be available through all the national drug wholesalers and chain drug stores and will begin shipping immediately, the company said.