Jazz Pharmaceuticals (JAZZ)

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On Thursday, Par Pharmaceutical Companies said that it has received final FDA approval for its Abbreviated New Drug Application for fluvoxamine maleate 100 mg and 150 mg extended-release capsules, a generic version of Jazz Pharmaceuticals’ Luvox CR, which is indicated for obsessive compulsive disorder. Par was the first firm to have submitted a substantially complete application containing a paragraph IV certification for fluvoxamine maleate 150 mg ER capsules, and has been awarded 180 days of marketing exclusivity for this strength; the firm has commenced shipping all approved strengths of the drug. IMS Health data reports that annual domestic sales of Luvox CR are roughly $51 million.

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