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news.The US Food and Drug Administration (FDA) has issued final approval to Perrigo's abbreviated new drug application (ANDA) for Desloratadine tablets (5 mg).
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Desloratadine, equivalent to Schering-Plough’s Clarinex tablets (5 mg), is indicated as a treatment for seasonal allergic rhinitis and perennial allergic rhinitis.
Perrigo was sued for patent infringement based upon its filing of an ANDA containing a Paragraph IV certification and settled the case in 2008.
The company received the regulatory agency’s nod to commercially launch its generic Desloratadine product most likely on 1 July 2012.
According to the company, the new product launch may be a prescription or over-the-counter (OTC) product depending on its status at the time of launch.
Perrigo chairman and CEO Joseph C Papa said the move by FDA represents the comapny’s commitment to bring new products to the market.