Final approval is expected upon expiry of patent protection for Novartis' Voltaren Ophthalmic Solution in October 2007.
Upon final approval, diclofenac sodium ophthalmic solution will be the generic equivalent of Novartis' Voltaren Ophthalmic Solution. The brand product had annual sales of approximately $22 million in 2005, based on IMS sales data.
“We are excited to receive this tentative approval for Diclofenac. This product will be manufactured in our Somerset, New Jersey facility,” said Arthur Przybyl, Akorn's president and CEO.
Akorn is headquartered in Buffalo Grove, Illinois and develops, manufactures and markets sterile specialty pharmaceuticals. Akorn markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals.