Perrigo Announces FDA Final Approval For Desloratadine

Main Category: Allergy
Also Included In: Ear, Nose and Throat;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 29 Dec 2011 - 1:00 PST


Perrigo Company (Nasdaq: PRGO;TASE) announced that it has received final approval from the U.S. Food and Drug Administration 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 over-the-counter (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 rhinitis. Sales for the brand were approximately $185 million, according to Wolters Kluwer data.

Perrigo's Chairman and CEO Joseph C. Papa stated, "This is another example of Perrigo's continued commitment to bring new products to the market. Perrigo continues to be focused on our mission of making quality healthcare more affordable for consumers."

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