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Home » AKORN'S GENERIC VOLTAREN GETS TENTATIVE APPROVAL
AKORN'S GENERIC VOLTAREN GETS TENTATIVE APPROVAL
The FDA has given Akorn tentative approval to market a generic version of Novartis' Voltaren Ophthalmic Solution, a drug used for the treatment of post-operative inflammation in ophthalmic surgeries.
Upon final approval, Akorn plans to market diclofenac sodium ophthalmic solution 1 percent in 2.5-mL and 5-mL dropper bottles. Final approval is likely to come in October 2007, when the patent protection expires.
The brand drug had annual sales of about $22 million in 2005, according to Akorn.
KEYWORDS FDAnews Drug Daily Bulletin
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