Perrigo today announced that its licensor and supplier Synthon
has received final approval from the FDA for Levocetirizine tablets, a generic
version of Xyzal tablets from UCB/Sepracor, which is marketed in the U.S. by Sanofi-Aventis.
Perrigo has the exclusive rights from Synthon to sell and distribute the
product in the U.S.
The Synthon product is the only approved generic product having a label
containing all indications as the brand product and is entitled to 180 days of
exclusivity for a product labeled for both allergy and hives. Product shipments
commenced immediately upon FDA approval.
Levocetirizine tablets (Xyzal) are indicated for the
treatment of indoor and outdoor allergies. According to Wolters Kluwer Health, sales
for Xyzal Tablets for the 12 month period ending September 2010, were $224
million, a 12% increase over the previous 12 month period.
Chairman and CEO Joseph C. Papa stated, “This is a terrific example of
Perrigo leveraging its strong partnerships in bringing new products to market.
We are excited to see the continued expansion of our generic Rx portfolio of
products.” Synthon’s CEO Rudy Mareel commented, “Levocetirizine is
one of several ANDAs for which Synthon has obtained ‘First-Filer’-status with
180 days Hatch-Waxman marketing exclusivity. We are proud of this achievement
and of our cooperation with Perrigo.”