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news.Perrigo, a global healthcare supplier of OTC and generic prescription pharmaceuticals, as well as infant formulas, nutritional products, APIs and medical diagnostic products, has filed an abbreviated new drug application (ANDA) with the US Food & Drug Administration (FDA) for calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment, generic forms of Taclonex Ointment.
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Taclonex ointment is indicated to topically treat psoriasis vulgaris in adults 18 years of age and older.
Perrigo notified Leo Pharma, the New Drug Application holder for Taclonex Ointment, after filing its ANDA containing a paragraph IV certification with the US Food & Drug Administration.
However, Leo filed suit on 14 February 2011 alleging patent infringement in the US District Court for the Southern District of New York to prevent Perrigo from proceeding with the commercialization of the product.
Perrigo chairman and CEO Joseph Papa said the filing is another example of the company’s commitment to invest in new products, focus on the extended topical generic space, and make quality healthcare affordable.