Akorn, Inc. (NASDAQ:AKRX) a niche generic pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s Erythromycin Ophthalmic Ointment USP 1 g as a supplement to the Company’s already approved Abbreviated New Drug Application (ANDA) for Erythromycin Ophthalmic Ointment USP 3.5 g. The company has begun shipping the product to its customers.
“Recent market shortages have made this an attractive product which is complimentary to the other ophthalmic ointments Akorn currently sells. 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.”
Raj Rai, Chief Executive Officer of Akorn stated, “Recent market shortages have made this an attractive product which is complimentary to the other ophthalmic ointments Akorn currently sells. 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 approximately $23 million.
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Akorn, Inc.