Torrent Pharma's Dubai unit has obtained tentative approval from FDA to market Cetirizine Hydrochloride Allergy tablets, in strengths of 5mg and 10mg, on over the counter basis.
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Cetrizine hydrochloride is a white, crystalline powder and is water soluble. It is the active component of cetrizine tablets and syrup. It is also an orally active and selective H1-receptor antagonist.
Cetrizine is indicated for relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in adults and children 6 months of age and older. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruitus, ocular pruritus, and tearing.
Cetrizine tablets are formulated for oral administration and are available in 5mg and 10mg strengths. Cetrizine Hydrochloride Allergy tablets fall under the generic drug category. Once granted complete approval by FDA, the tablets will be sold over the counter.
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