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The FDA has approved Akorn Inc.?s erythromycin ophthalmic ointment USP 1 g as a supplement to the company?s already approved abbreviated new drug application for erythromycin ophthalmic ointment USP 3.5 g
Lake Forest, IL-The FDA has approved Akorn Inc.’s erythromycin ophthalmic ointment USP 1 g as a supplement to the company’s already approved abbreviated new drug application for erythromycin ophthalmic ointment USP 3.5 g, according to the company.
The company has begun shipping the product to its customers.
“Recent market shortages have made this an attractive product, [and it] is complementary to the other ophthalmic ointments Akorn currently sells,” said Raj Rai, chief executive officer of Akorn. “This approval gives us access to both the sizes of erythromycin ophthalmic ointment and positions us to compete effectively in all channels through which the product is sold.”
According to IMS Health, the annualized U.S. sales for erythromycin 1 g based on second quarter 2010 data were about $23 million.