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FDA gives OTC Zyrtec the all clear

The FDA approves tablet, chewable tablet, and syrup formulations of Zyrtec for US OTC use in children and adults

The FDA has approved tablet, chewable tablet, and syrup formulations of Zyrtec (cetirizine) for OTC use in children and adults.

Zyrtec D tablets and chewable tablets are approved for adults and in children aged six years or older for the treatment of the symptoms of hay fever and other respiratory allergies, and to relieve the itching due to skin irritation.

Zyrtec D syrup is approved for adults and in children aged two years and older for the treatment of the symptoms of hay fever and other respiratory allergies. It is also approved for adults and children aged six year and older to relieve the itching due to skin irritation

Sales of the Zyrtec-D are subject to restrictions in the Combat Methamphetamine Epidemic Act. The US law places restrictions on the sale of products containing pseudoephedrine, such as limiting the amount that an individual can purchase, and imposing record keeping requirements on the retail establishments that sell the product and that it be located with the pharmacist.

Zyrtec is marketed and distributed by McNeil Consumer Healthcare, a one-time subsidiary of US-based Pfizer. In 2006, Johnson & Johnson (J&J) bought Pfizer Consumer Healthcare, combining the first and third ranked companies in the US market.

Pfizer's exit from the US OTC market echoed that of Bristol-Myers Squibb (BMS) selling its OTC portfolio to Novartis in 2005 and Boots International selling its US healthcare division to Reckitt Benckiser in the same year. Such deals continue to be the primary growth strategy for major OTC manufacturers as they combat an increasingly mature US marketplace.

30th September 2008

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