U.S. Pharmacist

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Perrigo and Synthon Announce Approval and Launch of Generic Xyzal

By Staff


1/20/2011

US Pharm. 2011;36(1):60.

Perrigo announced that its licensor and supplier Synthon has received final approval from the FDA for levocetirizine tablets, a generic version of Xyzal Tablets (UCB/Sepracor), which is marketed in the United States by Sanofi-Aventis. Perrigo has exclusive rights from Synthon to sell and distribute the product in the U.S. The Synthon product is entitled to 180 days of exclusivity for a product labeled for both allergy and hives and is the only approved generic product having a label containing all the same indications as the brand product. Levocetirizine tablets are indicated for the treatment of indoor and outdoor allergies. Sales for Xyzal Tablets for the 12-month period ending September 2010 were $224 million, a 12% increase over the previous 12-month period, according to Wolters Kluwer Health.

Synthon's CEO, Rudy Mareel, said, “Levocetirizine is one of several ANDAs for which Synthon has obtained 'First-Filer'-status with 180 days Hatch-Waxman marketing exclusivity. We are proud of this achievement and of our cooperation with Perrigo.”
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U.S. Pharmacist is a monthly journal dedicated to providing the nation's pharmacists with up-to-date, authoritative, peer-reviewed clinical articles relevant to contemporary pharmacy practice in a variety of settings, including community pharmacy, hospitals, managed care systems, ambulatory care clinics, home care organizations, long-term care facilities, industry and academia. The publication is also useful to pharmacy technicians, students, other health professionals and individuals interested in health management. Pharmacists licensed in the U.S. can earn Continuing Education credits through Postgraduate Healthcare Education, LLC, accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

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