Akorn, Inc. Announces FDA Approval of Ciprofloxacin HCl Ophthalmic Solution USP, 0.3%
LAKE FOREST, Ill., Dec 12, 2008 (BUSINESS WIRE) -- Akorn, Inc. today announced that the U.S. Food and Drug Administration has granted approval for Akorn's Abbreviated New Drug Application (ANDA) for Ciprofloxacin HCl Ophthalmic Solution USP, 0.3%.
Ciprofloxacin HCl Ophthalmic Solution is indicated for the treatment of infections caused by microorganisms in corneal ulcers and conjunctivitis. Annual sales for Ciprofloxacin HCl Ophthalmic Solution are approximately $20 million, according to IMS sales data. Akorn expects to launch Ciprofloxacin in 2009.
Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "This product approval represents our 20th product approval received in 2008, including our NDA approval for Akten(TM) and our joint venture product approvals. I would like to personally congratulate our Regulatory Affairs department for their efforts. Of the 20 product approvals received in 2008, 8 were launched in 2008 and 10 are scheduled for launch in the first half of 2009."
About Akorn, Inc.
Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company's website at www.akorn.com [1].
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SOURCE: Akorn, Inc.
Akorn, Inc.
Arthur S. Przybyl
President and CEO
(847) 279-6100
Links:
[1] http://www.akorn.com