Perrigo Company today announced that its partner, Teva Pharmaceutical Industries Ltd. , has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for over-the-counter Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Extended-Release Tablets, 5 mg/120 mg.
The product will be marketed by Perrigo under store brand labels and is comparable to McNeil Consumer Healthcare's recently launched Zyrtec-D(R) Extended-Release Tablets, indicated for 12 hour relief of indoor and outdoor allergy symptoms and nasal congestion. According to Wolters Kluwer data, brand sales for the original prescription strength version of the product for the 12 months ending December 2007 were approximately $190 million.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This approval and marketing agreement reflect our strategy to be first to market with the important products that make quality healthcare more affordable for our customers and drive value for our shareholders."
The Company expects to begin shipping the product in the next 90 days.
No comments:
Post a Comment