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FDA grants tentative approval to generic diclofenac

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BUFFALO GROVE, Ill. — The Food and Drug Administration has granted tentative approval to Akorn Inc. for a generic formulation of diclofenac sodium in 2.5 mL and 5 mL dropper bottles, the company announced in a press release.

Upon approval, the company's diclofenac sodium ophthalmic solution 0.1% will be a generic equivalent of Voltaren (diclofenac sodium, Novartis), which is indicated for treatment of postoperative inflammation from ophthalmic surgery, according to the release.

Final FDA approval of Akorn's formulation is expected after Voltaren's patent expires in October 2007, company officials said in the release.