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news.Synthon , Perrigo's licensor and supplier, has received final approval from the US Food and Drug Administration (FDA) for Levocetirizine tablets, a generic version of Xyzal tablets from UCB/Sepracor, which is marketed in the US by Sanofi-Aventis.
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Perrigo has the exclusive rights from Synthon to sell and distribute the product in the US.
Synthon claims that its product is the only approved generic product having a label containing all indications as the brand product and is entitled to 180 days of exclusivity for a product labeled for both allergy and hives. Product shipments commenced immediately upon FDA approval.
Levocetirizine tablets (Xyzal) are indicated for the treatment of indoor and outdoor allergies.
Synthon CEO Rudy Mareel said that 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," Mareel said.