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news.The US Food and Drug Administration's (FDA) has granted tentative approval for Perrigo's partner Synthon Pharmaceuticals' Levocetirizine Solution, 2.5mg/5ml abbreviated new drug application (ANDA).
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Levocetirizine Solution, 2.5 mg/5ml is the generic version of UCB’s Xyzal Oral Solution, indicated for the treatment of indoor and outdoor allergies.
Synthon and UCB are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Synthon ANDA filing.
Rudy Mareel CEO Synthon said Levocetirizine is a prime example of several ANDAs for which Synthon has obtained ‘First-Filer’-status with 180 days Hatch-Waxman marketing exclusivity.
Perrigo is a developer, manufacturer and distributer of OTC and generic prescription (Rx) pharmaceuticals.
Synthon Pharmaceuticals markets generic drugs through partnerships with other pharmaceutical companies.