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news.Perrigo has reported that its partner, Teva Pharmaceutical Industries has received final approval from the FDA for its abbreviated new drug application for over-the-counter Cetirizine hydrochloride, Pseudoephedrine hydrochloride extended-release tablets, 5 mg/120 mg.
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The product will be marketed by Perrigo under store brand labels and is comparable to McNeil Consumer Healthcare’s recently launched Zyrtec-D extended-release tablets, indicated for 12 hour relief of indoor and outdoor allergy symptoms and nasal congestion. The company expects to begin shipping the product in the next 90 days.
Joseph Papa, chairman and CEO of Perrigo said: “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.”