Perrigo Gets FDA Final Approval for Desloratadine
Perrigo has received final approval from the FDA for its ANDA for Desloratadine tablets.
US-based healthcare supplier Perrigo Company has received final approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Desloratadine tablets (5 mg).
Perrigo had been sued for patent infringement based upon its filing of an ANDA containing a Paragraph IV certification and settled the case in 2008. Under the terms of the settlement, Perrigo can commercially launch its generic Desloratadine product on July 1, 2012, or earlier in certain circumstances. The new product launch may be a prescription or OTC product depending on its status at the time of launch.
This product is an AB-rating as equivalent to Schering-Plough's Clarinex? tablets (5 mg) indicated for the treatment of seasonal allergic rhinitis and perennial allergic r
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