FDA Approval For Cetirizine Hydrochloride Tablets (OTC) ANDA - Hay Fever And Other Respiratory Allergies

Main Category: Respiratory / Asthma
Also Included In: Regulatory Affairs / Drug Approvals;  Allergy;  Pediatrics / Children's Health
Article Date: 29 Jul 2009 - 1:00 PST

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Taro Pharmaceutical Industries Ltd. reported that it has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for cetirizine hydrochloride tablets (OTC), 5 mg and 10 mg ("Cetirizine Tablets"). The product will be marketed by Taro's U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc.

Taro's Cetirizine Tablets are bioequivalent to McNeil Consumer Healthcare's Zyrtec® Allergy Tablets, 5 mg and 10 mg and Zyrtec® Hives Relief Tablets, 5 mg and 10 mg. Taro previously received approval for cetirizine hydrochloride oral solution in April 2008.

Cetirizine Tablets are a nonprescription drug approved for the temporary relief of symptoms due to hay fever or other respiratory allergies (sneezing; runny nose; itchy, watery eyes; itchy throat or nose) in adults and children 2 years of age and older. Cetirizine Tablets are also approved for the relief of itching due to hives in adults and children 6 years of age and older.

According to industry sources, annual U.S. sales of this product are approximately $350 million.

Taro is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.

Source
Taro Pharmaceutical Industries Ltd