PERRIGO'S CLOBETASOL PROPIONATE FOAM RECEIVES TENTATIVE APPROVAL
Perrigo announced that its Perrigo Israel Pharmaceuticals subsidiary has been granted tentative approval from the FDA for its abbreviated new drug application (ANDA) for clobetasol propionate topical foam, 0.05 percent. The reference drug, Connetics' Olux Foam, is subject to a period of patent protection. Perrigo filed its ANDA with a paragraph IV patent certification stating that the patent is invalid, unenforceable or will not be infringed on by this drug.
Final approval will not be granted until the expiration of the 30-month period provided under the Hatch-Waxman Act, unless, before that time, the patent expires or is judged to be invalid or not infringed on. In October 2005, Connetics filed suit in the U. S. District Court of New Jersey to prevent Perrigo from proceeding with the commercialization of its product. Litigation is currently ongoing.
If successful in the legal action, and upon final approval, Perrigo expects to be granted 180 days of generic marketing exclusivity. Clobetasol propionate foam is a topical corticosteroid is indicated for treating psoriasis.
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