Perrigo Company today announced that its partner Synthon Pharmaceuticals, Inc. has filed an Abbreviated New Drug Application (ANDA) for Levocetirizine solution 2.5mg/5ml, a generic version of Xyzal(R) solution 2.5mg/5ml. Under terms of an exclusive agreement between the companies, Perrigo has sales and marketing rights in Synthon's Levocetirizine products. The Company believes that Synthon is the first to file an ANDA with a Paragraph IV certification against Xyzal(R) solution that can entitle it to 180 days of generic exclusivity upon approval.
The details can be read here.
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